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NCT05561127PHASE3Recruiting

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel

GIE Medical

Start Date

11/1/2023

Completion Date

6/1/2032

Summary

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

Eligibility Criteria

Age Range: 22 years to No maximum

Inclusion Criteria: 1. Age ≥ 22 2. Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations. 3. Willing and able to complete protocol required follow up 4. Willing and able to provide written informed consent 5. Stricture length ≤ 5 cm Exclusion Criteria: 1. Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months 2. Contraindication to endoscopy, anesthesia, or deep sedation. 3. Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator. 4. Benign stricture due to extrinsic compression 5. Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.) 6. Stricture complicated with abscess, fistula, perforation, leakage or varices 7. Stricture segment has moderate to severe active inflammation at the time of treatment. Moderate to severe inflammation is defined as any one of; ulcers \>0.5cm in diameter, ulcerated surface \>10%, affected (inflamed) surface \>50%, marked erythema, absent vascular pattern, significant friability, or erosions 8. Multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be ≤5cm) NOTE: Clinically significant strictures include those that are unable to be passed by the endoscope. 9. Received steroid injections into target stricture in the last 8 weeks 10. Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel 11. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer) 12. Suspected perforation of gastrointestinal tract 13. Active systemic infection 14. Allergy to paclitaxel 15. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines 16. Chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use 17. Condition requiring treatment in urgent setting 18. Life expectancy of less than 24 months 19. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, etc. 20. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up

Interventions

COMBINATION_PRODUCT

GIE Medical ProTractX3 TTS DCB

OTHER

Control

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Conditions

Bowel; Stricture

Locations

Honor Health

Scottsdale, Arizona 85258

United States

University of California, Irvine

Irvine, California 92697-7600

United States

Gastro Care Institute

Lancaster, California 93534

United States

Cedars Sinai

Los Angeles, California 90048

United States

San Diego Gastroenterology

San Diego, California 92103

United States

University of Colorado Anschutz

Aurora, Colorado 80045

United States

University of Florida

Gainesville, Florida 32610

United States

Borland-Groover

Jacksonville, Florida 32256

United States

Research Associates of South Florida

Miami, Florida 33134

United States

Hillcrest Medical Research

Orange City, Florida 32763

United States

Orlando Health

Orlando, Florida 32806

United States

Orlando Health

Orlando, Florida 32806

United States

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia 31210

United States

Rush University

Chicago, Illinois 60612

United States

Kansas Gastroenterology, LLC

Wichita, Kansas 67226

United States

University of Louisville

Louisville, Kentucky 40202

United States

Tandem Clinical Research

Marrero, Louisiana 70072

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Washington University

St Louis, Missouri 63130

United States

Rutgers University

Piscataway, New Jersey 08854

United States

New York Presbyterian Hospital- Columbia University Medical Center

New York, New York 10027

United States

Lenox Hill Hospital

New York, New York 10075

United States

University of North Carolina

Chapel Hill, North Carolina 27599-1350

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Einstein Medical Center

Philadelphia, Pennsylvania 19107

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Allegheny Health Network

Pittsburgh, Pennsylvania 15212

United States

Vanderbilt University Medical Center

Nashville, Tennessee 27232

United States

Baylor St. Luke's Medical Center

Houston, Texas 77030

United States

The University of Utah

Salt Lake City, Utah 84108

United States

Virginia Mason

Seattle, Washington 98101

United States

Swedish Medical Center

Seattle, Washington 98122

United States

West Virginia University

Morgantown, West Virginia 26501

United States