MedTrace Logo

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

NCT05561127 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2025-06-25

No results posted yet for this study

Summary

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

Conditions

  • Bowel; Stricture

Interventions

COMBINATION_PRODUCT

GIE Medical ProTractX3 TTS DCB

The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

OTHER

Control

Standard of Care Endoscopic Dilation

Sponsors & Collaborators

  • GIE Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2027-12-01
Completion
2032-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561127 on ClinicalTrials.gov