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.
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