Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
- Conditions
- Bowel; Stricture
- Interventions
- Other: ControlCombination Product: GIE Medical ProTractX3 TTS DCB
- Registration Number
- NCT05561127
- Lead Sponsor
- GIE Medical
- Brief Summary
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 171
- Age ≥ 22
- Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
- Willing and able to complete protocol required follow up
- Willing and able to provide written informed consent
- Stricture length ≤ 5 cm
- Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
- Contraindication to endoscopy, anesthesia, or deep sedation.
- 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.
- Benign stricture due to extrinsic compression
- Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
- Stricture complicated with abscess, fistula, perforation, leakage or varices
- 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
- 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.
- Received steroid injections into target stricture in the last 8 weeks
- Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel
- 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)
- Suspected perforation of gastrointestinal tract
- Active systemic infection
- Allergy to paclitaxel
- Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
- 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
- Condition requiring treatment in urgent setting
- Life expectancy of less than 24 months
- 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.
- Current participation in another pre-market drug or medical device clinical study unless in long term follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Standard of Care. GIE Medical ProTractX3 TTS DCB GIE Medical ProTractX3 TTS DCB The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
- Primary Outcome Measures
Name Time Method Freedom from Stricture Recurrence 6 Months Post-Treatment Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Primary Safety Outcome 30 Days Post-Treatment Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
- Secondary Outcome Measures
Name Time Method Improvement in GIQLI-10 score 6 Months Post-Procedure The Gastrointestinal Quality of Life Index (GIQLI) is a validated questionnaire developed as a health-related quality of life assessment tool for patients with gastrointestinal diseases. The items on the GIQLI-10 align closely with common obstructive symptoms found in patients with bowel strictures.
Freedom from clinically driven target stricture reintervention 6 Months Post-Procedure Freedom from clinically driven reintervention represents freedom from repeat dilation, incision, or surgical management of the target stricture for recurrent obstructive symptoms.
Trial Locations
- Locations (32)
Cedars Sinai
🇺🇸Los Angeles, California, United States
Kansas Gastroenterology, LLC
🇺🇸Wichita, Kansas, United States
Honor Health
🇺🇸Scottsdale, Arizona, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Gastro Care Institute
🇺🇸Lancaster, California, United States
San Diego Gastroenterology
🇺🇸San Diego, California, United States
University of Colorado Anschutz
🇺🇸Aurora, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Borland-Groover
🇺🇸Jacksonville, Florida, United States
Research Associates of South Florida
🇺🇸Miami, Florida, United States
Hillcrest Medical Research
🇺🇸Orange City, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Gastroenterology Associates of Central Georgia, LLC
🇺🇸Macon, Georgia, United States
Rush University
🇺🇸Chicago, Illinois, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Washington University
🇺🇸St Louis, Missouri, United States
Rutgers University
🇺🇸Piscataway, New Jersey, United States
New York Presbyterian Hospital- Columbia University Medical Center
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor St. Luke's Medical Center
🇺🇸Houston, Texas, United States
The University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Mason
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States