Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
ConditionEsophageal Stricture
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorGIE Medical
About this trial
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Eligibility criteria
Qualifiers
Age ≥ 22 years
Diagnosis of a benign esophageal stricture with at least 2 previous dilations
Ogilvie Dysphagia Score of ≥2
Minimum esophageal lumen diameter <13 mm
Disqualifiers
Two or more clinically significant (e.g. non-traversable) strictures with total length >5cm or unable to be treated with a single balloon.
Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months
Contraindication to endoscopy, anesthesia or deep sedation
Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment.
Trial design
Treatments tested in this trial
- GIE Medical ProTractX3 TTS DCB
- Control
Treatment groups
198 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov