Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
PATENT-B
1 other identifier
interventional
171
1 country
33
Brief Summary
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2023
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2022
CompletedFirst Posted
Study publicly available on registry
September 30, 2022
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2032
June 25, 2025
June 1, 2025
4.1 years
September 27, 2022
June 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Freedom from Stricture Recurrence
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
6 Months Post-Treatment
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
30 Days Post-Treatment
Secondary Outcomes (2)
Freedom from clinically driven target stricture reintervention
6 Months Post-Procedure
Improvement in GIQLI-10 score
6 Months Post-Procedure
Other Outcomes (7)
Surgery Free Survival
30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Improvement in GIQLI-10
30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Technical Success
30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
- +4 more other outcomes
Study Arms (2)
GIE Medical ProTractX3 TTS DCB
EXPERIMENTALThe ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Control
ACTIVE COMPARATORStandard of Care.
Interventions
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GIE Medicallead
Study Sites (33)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2022
First Posted
September 30, 2022
Study Start
November 1, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2032
Last Updated
June 25, 2025
Record last verified: 2025-06