Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Age ≥ 22 years

• Diagnosis of a benign esophageal stricture with at least 2 previous dilations

• Ogilvie Dysphagia Score of ≥2

• Minimum esophageal lumen diameter \<13 mm

• Willing and able to complete protocol required follow-up visits

• Willing and able to provide written informed consent

• Strictures ≤5cm in total length

• Target benign esophageal stricture etiologies include:

‣ Peptic stricture,

⁃ Schatzki's ring,

⁃ Stricture due to prior infection,

⁃ Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture

⁃ Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy

Locations
United States
Alabama
Birmingham Gastroenterology Associates
NOT_YET_RECRUITING
Birmingham
Arizona
Honor Health
RECRUITING
Scottsdale
California
University of California, Irvine
RECRUITING
Irvine
Gastro Care Institute
RECRUITING
Lancaster
Cedars Sinai
RECRUITING
Los Angeles
San Diego Gastroenterology
RECRUITING
San Diego
Colorado
University of Colorado Anschutz
RECRUITING
Aurora
Florida
University of Florida
RECRUITING
Gainesville
Borland-Groover
RECRUITING
Jacksonville
Research Associates of South Florida
RECRUITING
Miami
Hillcrest Medical Research
RECRUITING
Orange City
Orlando Health
RECRUITING
Orlando
Georgia
Gastroenterology Associates of Central Georgia, LLC
RECRUITING
Macon
Illinois
Rush University
RECRUITING
Chicago
Kansas
Kansas Gastroenterology, LLC
RECRUITING
Wichita
Kentucky
University of Louisville
RECRUITING
Louisville
Louisiana
Tandem Clinical Research
RECRUITING
Marrero
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Missouri
Washington University
RECRUITING
St Louis
North Carolina
University of North Carolina Chapel Hill
RECRUITING
Chapel Hill
New Jersey
Rutgers University
RECRUITING
Piscataway
Nevada
Sierra Clinical Research
RECRUITING
Las Vegas
New York
New York Presbyterian Hospital- Columbia University Medical Center
RECRUITING
New York
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
Einstein Medical Center
RECRUITING
Philadelphia
Thomas Jefferson University
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Allegheny Health Network
RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor St. Luke's Medical Center
RECRUITING
Houston
TEN20 Clinical Research
RECRUITING
Plano
Utah
The University of Utah
RECRUITING
Salt Lake City
Washington
Swedish Medical Center
RECRUITING
Seattle
West Virginia
West Virginia University
RECRUITING
Morgantown
Contact Information
Primary
Erika Wang
wange@giemedical.com
7633605659
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2031-04
Participants
Target number of participants: 198
Treatments
Experimental: GIE Medical ProTractX3 TTS DCB
The ProTractX3 Drug-coated balloon is a 0.035 guidewire compatible over-the-wire catheter.
Active_comparator: Control
Standard of Care Endoscopic Dilation
Related Therapeutic Areas
Sponsors
Leads: GIE Medical

This content was sourced from clinicaltrials.gov