Neoplasms

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Breast Neoplasms

AeroForm Tissue Expansion inflation with carbon dioxide by remote control

Saline Tissue Expansion inflated by needle injections of saline

The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.

AeroForm Tissue Expansion

A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.

Saline Tissue Expansion

Jeffrey A. Ascherman, M.D.

This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.

This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).

Patient Controlled Tissue Expansion for Breast Reconstruction

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.

The median number of days taken to complete the expansion process.

AirXpanders, Inc.

All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99).

AEs assessed by investigators for severity, seriousness and relationship to device or procedure.

AEs coded to MedDRA standardized terms.

AeroForm Tissue Expansion inflation with carbon dioxide by remote control

AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.

Saline Tissue Expansion inflated by needle injections of saline

Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Device improvements occurred during the study with later subjects completing the study with a revised version of the device.

Results include all subjects treated in the study, regardless of device version.

Director of Clinical Affairs

The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \< πTreatment - πControl).

Primary Analysis Population (Per Protocol Cohort) = Subjects with an expander implanted successfully with no major protocol violation (evaluated per breast). Subjects who had a bilateral procedure have each breast evaluated separately.

Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event

All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days)

Expansion Days

Overall Study

Breast Diseases

Skin Diseases

Post-mastectomy patients undergoing expander reconstruction

Patient activated controlled expansion for post-mastectomy breast reconstruction

Patient Activated Controlled Expansion Device

Anthony Connell, M.D.

The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.

Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy.

Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome.

Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial.

Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months.

Patients will be instructed on the tissue expansion protocol pre-operatively and undergo post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by the treating surgeon.

Each patient will be followed through removal of the tissue expander.

Study Population:

The study population will consist of up to 10 patients. Eligible patients are females between the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery following mastectomy. Eligible patients must be able to provide informed consent and understand protocol components.

Patient Activated Controlled Expansion (PACE) Trial

Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).

The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.

Contour Profile Tissue Expander

John YS Kim, MD, MA

The purpose of this study is to explore the volume change and location of volume change in reconstructed breasts using the Contour Profile® tissue expander. Our purpose is also to investigate the safety of using CPX3® in tissue-expander breast reconstruction via a comparison between the complication rates that result from this study and the complication rates with the use of other tissue expander types, as reported in the literature. We also hope to demonstrate the use of 3-D imaging technology as an objective measure of upper and lower breast volume change and location of this volume change in the reconstructed breast. Finally, we intend to provide reconstructive surgeons with a scientific study that quantifies the patient satisfaction with aesthetic results of CPX3 in tissue expander-implant breast reconstruction. We hypothesize that the CPX3 tissue expander will provide more lower pole volume expansion when compared to lower pole volume expansion from round, standard tissue expanders as reported in the literature. Additionally, we hypothesize that CPX3, in combination with human acellular dermis, is less prone to complications than standard tissue expanders (again, as reported in the literature).

Tissue expansion is an accepted and widely used method for breast reconstruction. A drawback in using standard tissue expanders is unwanted fullness at the upper pole and insufficient expansion at the lower pole of the breast. Round expanders can result in poor ptosis (sagging) because of unwanted upper pole fullness and are not without risk for complications\[1, 2\]. Anatomically-shaped expanders also have shortcomings and complications such as malposition\[3-7\]. A tissue expander designed to counteract upper pole fullness is necessary to achieve a more natural appearing ptotic breast with a well-defined inframammary fold (IMF)\[8\]. The inframammary fold is the crease below the breast where the breast meets the chest wall. Mentor's Contour Profile® (CPX3) tissue expander provides a design with a greater height to width ratio for greater lower pole expansion. It also has suture tabs on the back of the expander to hold the expander in place and prevent malposition. Another recent advancement in tissue expander breast reconstruction is the use of cadaveric-derived human acellular dermis for rapid intraoperative expansion and early projection\[9-14\].

The crescent-shaped expander has been studied by John YS Kim, MD in a retrospective review of 40 consecutive patients who underwent acellular dermis assisted breast reconstruction. He found the crescentric tissue expansion with acellular dermis is well tolerated with high patient and surgeon satisfaction likely due to selective lower pole expansion related to the crescent shape, as well as significant immediate expansion related to larger subpectoral pockets.

To date, no studies have been reported that investigate the lower pole expansion resulting from varying tissue expander dimensions with objective computer software\[15, 16\]. The advent of three-dimensional imaging technology to objectively measure lower pole expansion provides a quantitative means to study the advantages of using the CPX3® tissue expander. We propose a study that will show whether or not the CPX3® tissue expander's unique design can have an ultimate effect on the shape and location of volume change on the postoperative breast. Three-dimensional cameras also provide an advantage for assessing patients undergoing bilateral mastectomy and reconstruction who desire a reconstructive outcome that will bear some resemblance to their current breasts \[15\].

The 3-D imaging calculation evaluates the following parameters: absolute volume, absolute volume change, location of expansion, base width, breast projection and contour symmetry. Older methods of volume assessment would assume that the base of the breast is a flat plane. The Vectra system takes into account the curvature of the chest wall, which results in a more accurate breast volume measurement. With 3-D imaging there is no exposure to radiation\[16\]. Another advantage to 3-D imaging is the option to view the subject's image at any angle, 360 degrees\[17\]. Our study would show the postoperative results of using the CPX3® tissue expander with an objective analysis of the degree of lower-pole expansion.

This will be a prospective study. Fifteen patients will be enrolled and will receive a Contour profile tissue expander (CPX3) during their reconstruction.

Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change

The Contour Profile® Tissue Expander in Immediate Breast Reconstruction: A Three-Dimensional Look Into Shape and Volume Changes

The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).

Mentor Worldwide, LLC

Northwestern University

Associate Professor Division of Plastic and Reconstructive Surgery

Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).

Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.

Contour Profile Tissue Exander

The number of subjects studied is small; projection measurements may have been subject to human error.

John Y.S. Kim, MD

Breast Projection

All patients recieving the intervention Alloderm for breast reconstruction

evenly placed vessel clips placed at surgery and tracked by ultrasound

5 mm vessel clips

aamir siddiqui, md

The purpose of this study is to evaluate the role of Alloderm tissue regenerative matrix used in many breast reconstruction operations. When this material is used in the abdomen it often stretches and sometimes needs to be replaced. Although we see good clinical results when used for breast reconstruction, there is no research regarding if or how the material changes in this location. The Alloderm is placed in the breast at the time the expander is placed, post-mastectomy. The expansion is started at the time of surgery and completed during a series of office visit. This process stretches the skin, underlying muscle and presumably the Alloderm. The goal of this study is to better understand the natural history of this material when used for breast reconstruction.

Our objective is to measure changes in the dimension of the tissue matrix material after it has been placed in the breast. These objective findings will be supplemented with a patient questionnaire specifically designed for breast surgery patients.

All patients will receive the standard preoperative work up, intraoperative procedures, and postoperative care indicated for patients undergoing implant breast reconstruction after mastectomy. Some of these patients will require use of the Alloderm to reconstruct the lower half of the breast pocket. This is already being done by plastic surgeons here at Henry Ford Hospital. The difference will be that the Alloderm tissue matrix used to reconstruct the lower part of the breast pocket for the study patients will have 4 millimeter metallic clips placed in it. Postoperatively these clips will be tracked by ultrasound done in the clinic. As the breast implant is normally expanded by adding saline, we believe the Alloderm matrix will stretch. The movement of these imperceptible clips will be tracked and measured to map the expansion of the matrix in response to the underlying implant stretching the overlying breast pocket and the skin envelope. The pattern of expansion will allow us to develop a mathematical model to describe the stretch pattern of Alloderm matrix used in breast reconstruction. This information will be supplemented with a validated questionnaire specifically designed by breast surgery patients. This will give us both an objective dimensional change in the breast reconstruction as well as a patient-centered evaluation of the reconstruction process.

1. Describe the experimental design/methodology.Prospective consecutive case series.
2. Outline the protocol, corresponding it to the specific aims; identify the data or endpoints to be analyzed to reach the specific aims.

   1. The first 3 candidates will serve as the prototypes for the model. There may be some unanticipated modifications to the setup, patient care, imaging or data analysis. We plan to follow these 3 cases more deliberately and not proceed until all 3 are followed for at least 3 months. After these 3 cases, we anticipate the rest will proceed more smoothly. Placement of the clips to provide the most data is the primary question for these 3 cases.

      The above schematic shows the presumed change is Alloderm size and shape post expansion and corresponding change in location of the vessel clips. The inferior borders is the fixed point. By positioning the clips at regular intervals along the top border, we can measure transverse and horizontal changes. The timing of ultrasound studies is designed to coincide with when these changes are most likely to be visualized during the postoperative period. We may change the dates of the studies. We do not anticipate the the total number of studies will increase because changes after full expansion (completed by postoperative week 4) are slower and smaller in magnitude.
   2. 30 patients enrolled in the study will be studied for position of the metallic markers on postoperative day 1, week 4, month 6, month 12. The location of each clip relative to the fixed anchor point will be recorded and each timepoint. The fixed anchor point is the medial-inner attachment point of the Alloderm® to the chest wall fascia. This is the most inferior/medial point of the Alloderm® tissue matrix. With expansion of the breast expander the chest wall fascia does not move. Only the overlying skin, pectoralis muscle and Alloderm stretch in response to breast prosthesis expansion. We can therefore track movement of the clips embedded in the matrix over time. For each clip we can develop a best fit curve for the 30 subjects studied. This will allow us to develop a mathematical model of the final position and shape of the reconstructed breast at one year out. This model will be compared to existing mathematical models for breast tissue expanders (Mentor Corp.
   3. A standardized validated questionnaire Breast-Q is a patient reported outcomes data instrument. The Breast-Q is conceptually grounded in patient perceptions, able to span the continuum of impact of surgery or validated against appropriate psychometric benchmarks. It allows for quantification of patient satisfaction and health-related quality of life experienced by women undergoing breast surgery. The questionnaire will be administered preoperative, one month postoperative and one year postoperative.

   The BREAST-Q scoring software, QScore, gives clinicians and researchers a simple and accurate way to analyze their data. It features a powerful scoring engine based on RUMM 2020; a data analyzing program developed by Rasch Unidimensional Measurement Models Laboratory in Perth, Australia.

   Each pre and postoperative BREAST-Q module comes with a Microsoft Excel template. The templates help to organize your data for import into the QScore program. Once imported, QScore automatically transforms your raw data into summary scores ranging from 0 (very dissatisfied) to 100 (very satisfied) for each scale.
3. Discuss potential limitations and difficulties in the protocol. Potential limitations include displacement of the vessel clips. If this happens, the patient's results and aesthetic outcome are not compromised. The clips do not cause any harm. These patients will be followed by standard of care protocol but removed from the study.
4. Provide a tentative schedule for conducting and completing this project and, if applicable, the multicenter study.

   The patients will be seen in the office at study enrollment and post surgery at one week, one month, six months and one years for evaluation ultrasound study. The Breast Q questionnaire will be completed preoperatively and then after surgery at one month and one year. one month and one year post surgery. We anticipated all patients enrolled within 6 months of study initiation. Total project should less than 2 years after last patient enrolled.
5. Data collection: Submit a copy of the data collection tool or list the data fields to be collected (review IRB policy, Access to Medical Records for Research on intranet at http://henry.hfhs.org).

Data entry points that will be collected include: The patient's name, age, history of steroid use, past medical history, date of surgery, size of graft used, thickness of the graft used. Also implant size, pre-surgery bra size, distance from each clip to inferiolateral anchor point on ultrasound.

7. DATA ANALYSIS: Describe the analysis of the data and relate this to the specific aims. Describe the statistical analysis in detail (referral to analysis by a multicenter sponsor is not acceptable). The Committee recommends free consultation with the Division of Biostatistics and Research Epidemiology.

There are two types of outcome measurements: the alloderm increased size and stardardized validated questionnaire. We will compare the difference between baseline and each time point after implant. For the alloderm increased size, the student paired-t statistic wil be used to test if there is any stretch in size. For questionnaire outcome, one-sample wilcoxon rank sum test will be used to test the difference in patient satisfication. Bonferrnoi correction is used for multiple comparison and the familywise type I error rate is set at 0.05.

Regenerative Tissue Matrix for Breast Reconstruction

In Situ Elasticity of Alloderm® in Breast Reconstruction

Henry Ford Health System

AamirSiddiqui, MD

Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.

Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.

6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.

Alloderm

10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.

Surgimend

Mark W. Clemens, MD

The goal of this clinical research study is to learn if the complication rate and post-surgical appearance differ based on what type of mesh is used for breast reconstruction surgery.

If you agree to take part in this study, you will be randomly assigned (as in the roll of a dice) to receive Surgimend mesh or Alloderm mesh.

Breast Reconstruction Surgery:

All techniques of the breast reconstruction surgery are considered to be standard of care. You will be given a separate consent form to sign that explains the procedure and risks in more detail.

Data Collection:

Information about you will be collected, including your age, height, weight, breast size, past medical and smoking history, tumor size and location, and the surgical method used for the breast reconstruction surgery.

Information about the breast reconstruction surgery, such as what type of expanders are used, the surgical methods, and your recovery from the surgery will also be collected.

Follow-Up Visits:

About 1 week after the breast reconstruction surgery is complete, you will come in for a follow-up visit and the surgical team will check the surgery incision site and tissue used for the breast reconstruction surgery for any possible complications.

About 2 weeks after the breast reconstruction surgery, the expansion process will begin, as long as you do not have any complications that would prevent beginning the expansion process. During the expansion process, the surgeon will adjust the tissue expanders to stretch the area under the skin and muscle to make room for a breast implant(s).

After you begin the expansion process, you will return to the clinic 1 time each week for additional expansion until the desired size is reached. During each of the expansion process visits, you will be checked for any side effects, including fluid build up and infection.

After the expansion process is complete, you will return to the clinic 3 months later to receive your implant(s). About 1 to 12 months after you receive the implant(s), you will return to the clinic and 5 photographs will be taken to evaluate the appearance of the new implant(s). The photographs will be taken of the front, right and left sides of the implant(s) site and will be taken against a blue background. Your private areas will be covered (as much as possible). Your confidentiality will be protected at all times. You will not be identifiable personally from the discussion or presentation of the data. Unique study numbers will be assigned to the photographs.

Length of Study:

Your participation on this study will be over after you have received your permanent breast implant(s) and the photographs have been taken.

This is an investigational study.

Up to 398 patients will take part in this study. All will be enrolled at the MD Anderson main campus or one of the MD Anderson regional care centers.

Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction

Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial

M.D. Anderson Cancer Center

Arm 1

Arm 2

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Guatemala

Dr. Mark W Clemens, Associate Professor, Plastic Surgery

Of the 90 randomized participants, 66 (74%) were evaluable for the primary measure

Number of Participants With Complications After Tissue Expander Replacement With Implant

Arm 1- Surgimend

Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.

Device: Alloderm 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient Controlled Tissue Expansion for Breast Reconstruction	NCT01425268	Breast Cancer	AeroForm Tissue... Saline Tissue E...	18 Years - 70 Years	AirXpanders, Inc.
Patient Activated Controlled Expansion (PACE) Trial	NCT01009008	Breast Cancer Mastectomy Breast Reconstr...	Patient Activat...	18 Years - 65 Years	AirXpanders, Inc.
Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change	NCT01222390	Contour Irregul...	Contour Profile...	25 Years - 85 Years	Northwestern University
Regenerative Tissue Matrix for Breast Reconstruction	NCT01027637	Breast Cancer	5 mm vessel cli...	18 Years - 70 Years	Henry Ford Health System
Patient Activated Controlled Expansion (PACE) Trial	NCT01009008	Breast Cancer Mastectomy Breast Reconstr...	Patient Activat...	18 Years - 65 Years	AirXpanders, Inc.
Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction	NCT01310075	Breast Cancer	Alloderm Surgimend	18 Years -	M.D. Anderson Cancer Center
Regenerative Tissue Matrix for Breast Reconstruction	NCT01027637	Breast Cancer	5 mm vessel cli...	18 Years - 70 Years	Henry Ford Health System

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