GIE Medical ProTractX3 TTS DCB: The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Control: Standard of Care Endoscopic Dilation
Study summary
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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)
Trial sites (33)
Facility
City
Region
Status
Honor Health
Scottsdale
Arizona
Recruiting
University of California, Irvine
Irvine
California
Recruiting
Gastro Care Institute
Lancaster
California
Recruiting
Cedars Sinai
Los Angeles
California
Recruiting
San Diego Gastroenterology
San Diego
California
Recruiting
University of Colorado Anschutz
Aurora
Colorado
Recruiting
University of Florida
Gainesville
Florida
Recruiting
Borland-Groover
Jacksonville
Florida
Recruiting
Research Associates of South Florida
Miami
Florida
Recruiting
Hillcrest Medical Research
Orange City
Florida
Not Yet Recruiting
Orlando Health
Orlando
Florida
Recruiting
Orlando Health
Orlando
Florida
Recruiting
Gastroenterology Associates of Central Georgia, LLC
Macon
Georgia
Recruiting
Rush University
Chicago
Illinois
Recruiting
Kansas Gastroenterology, LLC
Wichita
Kansas
Recruiting
University of Louisville
Louisville
Kentucky
Recruiting
Tandem Clinical Research
Marrero
Louisiana
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Recruiting
Washington University
St Louis
Missouri
Recruiting
Rutgers University
Piscataway
New Jersey
Recruiting
New York Presbyterian Hospital- Columbia University Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.