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

Conditions

• Bowel; Stricture

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GIE Medical ProTractX3 TTS DCB — COMBINATION_PRODUCT
  The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
• Control — OTHER
  Standard of Care Endoscopic Dilation

Study Details

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

Key Dates

Start date

Nov 1, 2023

Status verified

Jun 2025

Primary completion

Dec 1, 2027

Completion

Jun 1, 2032

Study Design

Enrollment

171 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Freedom from Stricture Recurrence [ Time Frame: 6 Months Post-Treatment ]

Central Contacts

• Erika Wang
  0000000000
  [email protected]

Locations (33)

Find similar trials in Scottsdale, AZ