Actively Recruiting
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
Led by GIE Medical · Updated on 2025-06-25
171
Participants Needed
33
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
CONDITIONS
Official Title
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- 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 or less
You will not qualify if you...
- Female subjects who are pregnant, breastfeeding, or plan to get pregnant in the next 12 months
- Contraindication to endoscopy, anesthesia, or deep sedation
- Suspicion of malignant bowel stricture
- Benign stricture due to extrinsic compression
- Stricture is not amenable to standard balloon dilation (e.g., severe angulation, unable to pass guidewire)
- Stricture complicated with abscess, fistula, perforation, leakage, or varices
- Moderate to severe active inflammation in the stricture segment at treatment time
- Multiple significant strictures unable to be treated with a single balloon (total length must be 5 cm or less)
- Received steroid injections into target stricture in the last 8 weeks
- Stricture cannot be dilated to at least 15 mm in small bowel or 18 mm in large bowel
- Diagnosis of metastatic cancer not in remission or non-metastatic cancer requiring pelvic radiation
- Suspected gastrointestinal tract perforation
- Active systemic infection
- Allergy to paclitaxel
- Severe coagulation disorders or use of anticoagulant/antiplatelet medication not safely managed
- Chronic systemic steroid use above 10 mg/day unless willing to undergo 4-week washout
- Condition requiring urgent treatment
- Life expectancy less than 24 months
- Concurrent medical conditions affecting safety or evaluation
- Current participation in another pre-market drug or medical device clinical study unless in long-term follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
University of California, Irvine
Irvine, California, United States, 92697-7600
Actively Recruiting
3
Gastro Care Institute
Lancaster, California, United States, 93534
Actively Recruiting
4
Cedars Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
5
San Diego Gastroenterology
San Diego, California, United States, 92103
Actively Recruiting
6
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
7
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
8
Borland-Groover
Jacksonville, Florida, United States, 32256
Actively Recruiting
9
Research Associates of South Florida
Miami, Florida, United States, 33134
Actively Recruiting
10
Hillcrest Medical Research
Orange City, Florida, United States, 32763
Not Yet Recruiting
11
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
12
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
13
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31210
Actively Recruiting
14
Rush University
Chicago, Illinois, United States, 60612
Actively Recruiting
15
Kansas Gastroenterology, LLC
Wichita, Kansas, United States, 67226
Actively Recruiting
16
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
17
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
Actively Recruiting
18
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
19
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
20
Rutgers University
Piscataway, New Jersey, United States, 08854
Actively Recruiting
21
New York Presbyterian Hospital- Columbia University Medical Center
New York, New York, United States, 10027
Actively Recruiting
22
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
23
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-1350
Actively Recruiting
24
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
26
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
27
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
28
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 27232
Actively Recruiting
29
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
30
The University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
31
Virginia Mason
Seattle, Washington, United States, 98101
Actively Recruiting
32
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
33
West Virginia University
Morgantown, West Virginia, United States, 26501
Actively Recruiting
Research Team
E
Erika Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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