GIE Medical
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
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 subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months 2. Contraindication to endoscopy, anesthesia, or deep sedation. 3. Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation…
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Standard of Care Endoscopic Dilation