Wounds and Injuries

All Conditions

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Surgical Wound

Tissue Adhesions

Constriction, Pathologic

Surgical Wound Dehiscence

Rectal Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

For use as a homologous tissue where native peritoneum is absent or traumatized. By decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. The combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy.

To investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients.

AlloMEM™

Conor P. Delaney, MD, PhD

The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.

A loop ileostomy is a common procedure used to divert fecal matter from anastomotic sites after abdominal surgeries. Major complications from creation and subsequent closure of a temporary loop ileostomy include: stoma retraction, stoma prolapsed, stenosis, herniation, intra-abdominal abscess, anastomotic leak, wound dehiscence. Small-bowel obstruction (SBO) was the most common complication. SBO is caused by adhesions in the surgical site, with narrowing or angulation of the intestine causing obstruction. Prevention of these adhesions may reduce the frequency with which SBO is seen after this surgery. Furthermore, surgery to close the ileostomy is complicated by the presence of adhesions which make dissection of the ileostomy difficult, and increase the risk of injury of the small intestine during dissection, prolonging the operation time in an effort to minimize risk to the patient.

AlloMEM™ is human peritoneal membrane designated by the Food and Drug Administration (FDA) for use as a homologous tissue where native peritoneum is absent or traumatized. The AlloMem™ is not regulated as a device and no 510k submission has been made by the FDA. AlloMem™ is allogeneic freeze-dried, irradiated human peritoneal membrane used as a soft tissue wound covering solely regulated under 361 HCT/P because by FDA definition it is: minimally manipulated; intended for homologous use only; does not involve the combination of cell or other tissues, and does not rely on the metabolic function of cells for its primary function. Two animal studies have shown that AlloMEM™ can help prevent intra-abdominal adhesions and provides the biological framework for peritoneal remodeling. By decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. The combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy.

Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

Pilot Study Evaluating the Efficacy of AlloMEM in Prevention of Intraperitoneal Adhesions & Peritoneal Regeneration After Loop Ileostomy

Change in adhesion formation will be analyzed via the primary outcome of ileostomy mobilization time during ileostomy closure and the secondary outcome of an adhesion grading scale.

The objective of this study is therefore, to investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling

Proxy Biomedical Limited

University Hospitals Cleveland Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Rare Diseases

Uterine Cervical Dysplasia

Pathological Conditions, Anatomical

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

Cervical Intraepithelial Neoplasia

The number of patients to be recruited in this arm will be 145. Note: The first twenty-five patients who will be included in the study will be allocated in the intervention arm to safety analysis (phase 1); after that all eligible candidates will be randomized 1:1 (phase 2).

Procedure: Loop Electrosurgical Excision Procedure (LEEP) followed by implantation of the device called DUDA (plastic device developed in barretos cancer hospital that will be placed after conization. It has 2.5 cm in length and 5mm in diameter and remains within the endocervical canal for 30 days and is set at 4 points with nonabsorbable sutures in the ectocervix.)

The number of patients to be recruited in this arm will be 120.

Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device

DUDA device

LEEP

Ricardo Reis, PHD

Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and amenorrhea. This study will test a new device named DUDA Device ("Dispositivo Uterino para dilatar canal endocervical") placed just after the conization, in order to evaluate the safety, efficacy and quality of life.

This device has the potential to improve outcomes by means of a significant stenosis reduction and maintain patency of the endocervical canal to view the squamo-columnar junction (SCJ) of the cervix during follow-up of this patient.

How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?

A Randomized Study to Evaluate the Safety, Efficacy and Quality of Life of a New Device to Prevent Cervical Stenosis After LEEP in High Grade Cervical Dysplasia

The main safety events to be considered in this analysis are vaginal bleeding and uterine infection. The device is considered unsafe and consequently disrupted the study if a two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5 related to the procedure/device happens during the phase 1.

Stenosis of the endocervical canal (early and late) will be assessed by clinical information and physical examination at each visit to the hospital after surgery. The participant will be asked about the menstrual flow and dysmenorrhea during history taking. On physical examination, after the visualization of the cervix through the speculum examination, the doctor will check the channel permeability introducing a hysterometer through it. The difficulty of introducing the hysterometer 2.5mm the channel will be scored according to the following scale:

Possible passage of hysterometer? () No difficulty () Little difficult, however possible passage of hysterometer () Unable to pass

The quality of life will be evaluated through questionnaires by the Functional Assessment of Cancer Therapy - Cervix Cancer (FACT-Cx) and the universal pain assessment tools that include international scale and pain visual analogue (EVA), numerical visual pain scale (EVN) and faces pain scales (EF).

It will be evaluated during the following returns and described as any event related directly to the use of DUDA device as metrorrhagia and uterine infection.

It will be assessed during the examination of colposcopy

Barretos Cancer Hospital

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Vasodilator Agents

All Drugs and Chemicals

Polymethyl Methacrylate

Test Product: OsseoScrew Spinal Fixation System

Control Product: Any commercially available fenestrated screw system augmented with PMMA

OsseoScrew Spinal Fixation System

Bita Ghadimi

The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.

This was a randomized, open-label, controlled, multi-center study in which patients were randomized in a 1:1 ratio to receive either the OsseoScrew or any commercially available fenestrated screw augmented with polymethylmethacrylate (PMMA) (Control group) for posterior spinal fixation after surgical correction of spinal deformity or pathology. The study was planned to include up to 150 skeletally mature patients with spinal instability and osteopenia at up to 10 sites. Patients were to return postoperatively at 6 weeks (± 2 weeks) and at 6, 12, and 24 months (± 2 months) for assessments.

OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

Expandable Pedicle Screws Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients With Osteoporosis or Poor Bone Quality

The proportion of patients who were free from device-related or PMMA-related complications leading to revision, supplemental fixation, non-elective removal, or reoperation throughout the study. Complications included, but were not limited to device or PMMA fracture, device or PMMA-related loosening, device or PMMA-related device disassembly, device migration or PMMA extravasation.

Presence of continuous bridging bone across the implant

This is a measure of the patient's self reported permanent functional disability. Each section is scored on a 1-5 scale with 5 representing the greatest disability.

This is a measure of the characteristic or attitude that is believed to range across a continuum of values to measure pain intensity. The range of score is from 0 - 100. The patient marks on the line the point that they feel represents their perception of their current state. A higher score indicates greater pain intensity.

Alphatec Spine, Inc.

Diseases and Abnormalities at or Before Birth

Scoliosis

Congenital Abnormalities

Kyphosis

Intervertebral Disc Degeneration

Pseudarthrosis

Spinal Curvatures

Spinal Diseases

Fractures, Bone

Fractures, Ununited

Use these system:

(1) SmartLoc (2) SmartLoc Evo(3) Winloc (4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L

As long as there are patients using the above device, conduct questionnaire interview.

(1) SmartLoc (2) SmartLoc Evo (3) Winloc(4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L

Shu-Ting LIU, MS

Bryan Huang, MD

This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.

The purpose of study is to confirm the safety and and performance of the A-SPINE's products for using 2 years. This post-market clinical follow-up study use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to evaluate the clinical improvement effects. Subjects will be evaluated at pre-operation, 6 months, 12 months, and 2 years post treatment. Finally, analyze the clinical outcome, fusion rate, and adverse events.

Post-Market Clinical Follow-up Study of A-SPINE's Products

Visual Analogue Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain. Compare baseline and postoperative improvement VAS scores.

The NDI is a questionnaire that is commonly used in clinical trials to measure the self-reported functional status of patients with neck pain.The ten questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). Compare baseline and postoperative improvement NDI scores.

The ODI is a questionnaire that is commonly used in clinical trials to measure the self-reported functional status of patients with neck pain.The ten questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). Compare baseline and postoperative improvement ODI scores.

Adverse events associated with the device will be assessed at each follow-up visit and the number of cases at the 2-year follow-up will be counted.

Use X-ray or CT to detect the spine fusion.

A-Spine Asia Co., Ltd.

Heart and Blood Diseases

Aneurysm

Arteriovenous Malformations

Hemangioma

Vascular Diseases

Vascular Malformations

Cardiovascular Abnormalities

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology

Normal dose DSA with conventional X-ray technology.

Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.

Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.

Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.

Normal dose DSA with conventional X-ray technology

Michael Söderman, MD, PhD

Tommy Andersson, MD, PhD

Staffan Holmin, MD, PhD

ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The final effect on the clinical image quality is investigated in this study.

The advent of interventional neuroradiology (INR) has changed the treatment of neurovascular diseases by reducing the procedural invasiveness and the recovery time needed by patients, thus improving clinical outcome. However, INR procedures often require many high-quality digital substraction angiography (DSA) runs and long total fluoroscopy times, which can result in patients being exposed to considerable radiation doses levels.

In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a real-time noise reduction algorithm for DSA in neuroradiology that is capable to reduce the patient entrance dose by 75% without loss of image quality.

Image Quality and Radiation Dose in Angiography

XRES4 Neuro Claim Study

Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.

The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics.

A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA.

Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.

Philips Medical Systems

Karolinska University Hospital

MD, PhD

Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ

AlluraXper - ClarityIQ

Angiogram with AlluraXper followed by angiogram with ClarityIQ

Age, Continuous

Sex: Female, Male

Sweden

Region of Enrollment

Dr. Söderman

Investigator 1

Investigator 2

Investigator 3

AlluraXper

Allura Clarity

Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.

All patients with recorded dose information and images for both angiograms were included (n=20)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy	NCT01113736	Colon Cancer Rectal Cancer	AlloMEM™	18 Years -	University Hospitals Cleveland Medical Center
Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy	NCT01113736	Colon Cancer Rectal Cancer	AlloMEM™	18 Years -	University Hospitals Cleveland Medical Center
How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?	NCT02500966	Stenosis Cervix	DUDA device LEEP	18 Years - 65 Years	Barretos Cancer Hospital
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate	NCT01613144	Osteoporosis Poor Bone Quali...	OsseoScrew Spin...	18 Years -	Alphatec Spine, Inc.
Post-Market Clinical Follow-up Study of A-SPINE's Products	NCT04848376	Degenerative Di... Kyphosis Scoliosis Trauma Tumor Stenosis Pseudoarthrosis... Deformity	(1) SmartLoc (2...	20 Years - 80 Years	A-Spine Asia Co., Ltd.
Image Quality and Radiation Dose in Angiography	NCT01381952	Arteriovenous M... Aneurysm Stenosis Dural Arteriove...	Low dose DSA (7... Normal dose DSA...	18 Years - 80 Years	Karolinska University Hospital
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate	NCT01613144	Osteoporosis Poor Bone Quali...	OsseoScrew Spin...	18 Years -	Alphatec Spine, Inc.

Spots Global Cancer Trial Database for stenosis

Every month we try and update this database with for stenosis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for stenosis

Every month we try and update this database with for stenosis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for stenosis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.