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

Conditions

• Esophageal Stricture

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GIE Medical ProTractX3 TTS DCB — COMBINATION_PRODUCT
  Paclitaxel Coated Balloon
• Control — OTHER
  Standard Endoscopic Dilation

Study Details

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

Key Dates

Start date

Dec 1, 2023

Status verified

Jun 2025

Primary completion

Oct 31, 2026

Completion

Apr 30, 2031

Study Design

Enrollment

198 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 Endoscopic Dilation

Primary Outcome Measure

Treatment Success [ Time Frame: 6 Months Post-Procedure ]

Central Contacts

• Erika Wang
  7633605659
  [email protected]

Locations (34)

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