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Breast Neoplasms

Breast Diseases

Skin Diseases

AeroForm Breast Tissue Expander placed after mastectomy

Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide

AeroForm Breast Tissue Expander

Tony Connell, F.R.A.C.S.

This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction

The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria

Study of AeroForm Tissue Expander for Breast Reconstruction

AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction

AirXpanders, Inc.

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.

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

Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).

Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant.

Breast Reconstruction, Direct to Implant (DTI) with Strattice™

Two Stage Breast Reconstruction

Donna Jacobs

The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.

The primary objective of this study is to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice™ TM, otherwise referred to as DTI as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander will be exchanged for a breast implant only, without any type of a reinforcement. The objective will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions within 12 months of the mastectomy.

Two-stage breast reconstruction will include the initial placement of a tissue expander in a total or partial submuscular position. In the case of partial muscle coverage, this will be without the support of any mesh or autologous flap to reinforce the lower pole. The expander will be inflated over approximately the next one to six months, and then replaced with an implant.

Single Stage Breast Reconstruction in Female Participants with Mastectomy

Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy

A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)

ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.

Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the infra-mammary fold (IMF). Serious BRRC were detected through review by a medical monitor. Surgical complications included: capsular contracture (Baker grade ≥ 3), infection (local or systemic), hematoma, seroma, inflammation, skin or flap necrosis, implant extrusion, malposition, malrotation, asymmetry, bottoming out.

Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the IMF. Serious BRRC were detected through review by a medical monitor. BRRC were defined as: a) infection, local or systemic, b) hematoma, c) seroma, d) inflammation, e) skin or flap necrosis, f) capsular contraction as defined by Baker grade \> 3, g) implant extrusion (loss or explants), and h) malposition, malrotation, asymmetry, and bottoming out.

The surgeon assessed the level of capsular contracture in the participant's breast using the Baker Breast Contracture Scale where: Grade I=breast is normally soft and looks natural, Grade II=breast is a little firm but looks normal, Grade III=breast is firm and looks abnormal and Grade IV= breast is hard, painful, and looks abnormal. Baker Grade III and IV were defined as clinically significant and are reported here. Data is presented for number of participants with capsular contracture per breast (right breast and left breast).

Surgical interventions were all planned and unplanned post-mastectomy surgical interventions per participant on the reconstructed breast, within 24 months of the ISS, which is defined as the DTI breast reconstruction with Strattice™ TM or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction.

LifeCell

The number of participants at risk for Serious Adverse Events and Other Adverse Events is based on the Safety Set. 4 participants did not have first surgery date and were not included in Safety Set.

Breast Reconstruction, Direct to Implant (DTI) With Strattice™

Black/African American

Caucasian

Other

Missing

Race/Ethnicity, Customized

Hispanic or Latino

Non-Hispanic or non-Latino

Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded.

Therapeutic Area, Head

Unilateral

Bilateral

Post-ISS analysis set consisted of all participants who underwent a mastectomy and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month \[365 days\]-4 week \[28 days\] window). Number analyzed is the number of participants with data available at the given time-point.

Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS)

Post-ISS analysis set consisted of all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month \[365 days\]-4 week \[28 days\] window).

Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)

ppR Follow-up set consisted of all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed the 24 months ppR visit. Participants whose 24-month visit was performed early due to termination of the study were also included.

Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)

Right breast (Grade III)

Right breast (Grade IV)

Left Breast (Grade III)

Left Breast (Grade IV)

Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded. Number analyzed for each category includes those participants for whom the Baker grade was assessed.

Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR

The independent reviewer panel was not established and data were not collected due to early termination of the study, hence this endpoint could not be analyzed.

Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel

Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded. Number analyzed is the number of participants with data available at the given time-point.

Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS

ppR Follow-up set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed 24 months ppR visit; whose 24-month visit was performed early due to termination of study were also included. Number analyzed is number of participants with data available at given time-point.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of AeroForm Tissue Expander for Breast Reconstruction	NCT01903174	Breast Cancer Breast Reconstr...	AeroForm Breast...	18 Years - 70 Years	AirXpanders, Inc.
Patient Controlled Tissue Expansion for Breast Reconstruction	NCT01425268	Breast Cancer	AeroForm Tissue... Saline Tissue E...	18 Years - 70 Years	AirXpanders, Inc.
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy	NCT01910298	Mastectomy and ...	Breast Reconstr... Two Stage Breas...	18 Years -	LifeCell

Spots Global Cancer Trial Database for two stage breast reconstruction