Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
ConditionBowel; Stricture
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorGIE Medical
About this trial
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Eligibility criteria
Qualifiers
Age ≥ 22
Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
Willing and able to complete protocol required follow up
Willing and able to provide written informed consent
Disqualifiers
Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
Contraindication to endoscopy, anesthesia, or deep sedation.
Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator.
Benign stricture due to extrinsic compression
Trial design
Treatments tested in this trial
- GIE Medical ProTractX3 TTS DCB
- Control
Treatment groups
171 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov