NCT05561127

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: GIE Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-11-01
• Primary completion: 2027-12-01
• Completion: 2032-06-01
• First posted: 2022-09-30
• Last updated: 2025-06-25

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated device study