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

Recruiting Phase 3 Interventional Study
Bowel; Stricture
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
22 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
171 (estimated)
Sponsor
GIE Medical · Industry
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About This Trial

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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 22 2. Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations. 3. Willing and able to complete protocol required follow up 4. Willing and able to provide written informed consent 5. Stricture length ≤ 5 cm Exclusion Criteria: 1. Female subje…
Contacts

Erika Wang

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wange@giemedical.com

CONTACT