Actively Recruiting
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
Led by GIE Medical · Updated on 2025-06-25
198
Participants Needed
34
Research Sites
382 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
CONDITIONS
Official Title
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Diagnosed with benign esophageal stricture with at least 2 previous dilations
- Ogilvie Dysphagia Score of 2 or higher
- Esophageal lumen diameter less than 13 mm
- Willing and able to complete all required follow-up visits
- Willing and able to provide written informed consent
- Strictures 5 cm or less in total length
- Target stricture types include peptic stricture, Schatzki's ring, stricture due to prior infection, post-procedural stricture (e.g. ESD/EMR/RFA/Cryo), and post-surgical stricture including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy
You will not qualify if you...
- Two or more clinically significant strictures with total length greater than 5 cm or not treatable with a single balloon
- Female subjects who are pregnant, breastfeeding, or plan to become pregnant within 12 months
- Contraindications to endoscopy, anesthesia, or deep sedation
- Benign esophageal strictures caused by extrinsic compression, caustic ingestion, lichen planus, or purely radiation-induced strictures from head/neck cancer treatment
- History of eosinophilic esophagitis
- Signs or suspicion of malignant esophageal stricture without biopsy confirmation
- Diagnosis of metastatic cancer not in remission or non-metastatic cancer that may require neck or thoracic radiation
- Suspected gastrointestinal tract perforation
- Inability to pass a guidewire across the stricture
- Active systemic infection
- Allergy to paclitaxel or related compounds
- Severe coagulation disorders or use of anticoagulant/antiplatelet medication that cannot be managed safely
- Chronic systemic steroid use unless willing to undergo 4-week washout
- Steroid injections into target stricture within the last 8 weeks
- Stricture not amenable to dilation to 18 mm or greater
- Current use of nasal or oral feeding tube without removal prior to baseline and normal swallowing function
- Acute stricture condition requiring emergency procedure
- Stricture complicated by abscess, fistula, deep ulceration, perforation, leakage, varices, or thrombosis
- Life expectancy less than 24 months
- Concurrent medical conditions affecting evaluation or safety such as recent heart attack, severe lung disease, bleeding disorders, large thoracic aneurysm, pharyngeal or cervical deformity, or ongoing infection
- Participation in another pre-market drug or device clinical study without primary endpoint reached
- Dysphagia related to primary motility disorders like achalasia or esophageal spasm
- Active erosive esophagitis grade B-D at endoscopy
- Significant proximal esophageal dilation that may affect motility
- Intolerance to acid suppression medications
- Concurrent gastric or duodenal obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
Birmingham Gastroenterology Associates
Birmingham, Alabama, United States, 35209
Not Yet Recruiting
2
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
University of California, Irvine
Irvine, California, United States, 92697-7600
Actively Recruiting
4
Gastro Care Institute
Lancaster, California, United States, 92534
Actively Recruiting
5
Cedars Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
6
San Diego Gastroenterology
San Diego, California, United States, 92103
Actively Recruiting
7
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
8
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
9
Borland-Groover
Jacksonville, Florida, United States, 32256
Actively Recruiting
10
Research Associates of South Florida
Miami, Florida, United States, 33134
Actively Recruiting
11
Hillcrest Medical Research
Orange City, Florida, United States, 32763
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
Sierra Clinical Research
Las Vegas, Nevada, United States, 89106
Actively Recruiting
21
Rutgers University
Piscataway, New Jersey, United States, 08854
Actively Recruiting
22
New York Presbyterian Hospital- Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
23
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
24
Oregon Health and Science University
Portland, Oregon, United States, 97229
Actively Recruiting
25
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
26
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
27
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
28
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
29
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
30
Baylor St. Luke's Medical Center
Houston, Texas, United States, 75246
Actively Recruiting
31
TEN20 Clinical Research
Plano, Texas, United States, 75093
Actively Recruiting
32
The University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
33
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
34
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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