Clinical trial NCT05561127: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
Official title: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bowel; Stricture
Keywords: dcb
bowel stricture
drug coated balloon
paclitaxel coated balloon
Lead sponsor: GIE Medical
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 171
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 outcomes:
measure: Freedom from Stricture Recurrence
timeFrame: 6 Months Post-Treatment
measure: Primary Safety Outcome
timeFrame: 30 Days Post-Treatment
Secondary outcomes:
measure: Freedom from clinically driven target stricture reintervention
timeFrame: 6 Months Post-Procedure
measure: Improvement in GIQLI-10 score
timeFrame: 6 Months Post-Procedure
Other outcomes:
measure: Surgery Free Survival
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Improvement in GIQLI-10
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Technical Success
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Improvement in EOS
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Dilations per year before and after treatment
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Time between dilations
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
measure: Estimated stricture diameter
timeFrame: 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: San Diego
country: United States
facility: San Diego Gastroenterology
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida
state: Florida
city: Orange City
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Wichita
country: United States
facility: Kansas Gastroenterology, LLC
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
city: New York
country: United States
facility: New York Presbyterian Hospital- Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: