Title: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus (PATENT-E)
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Sponsor: GIE Medical.
Primary Investigator: Gregory Ginsberg, MD
CONTACT: Christine Gepty (christine.gepty@pennmedicine.upenn.edu or 215-349-8556)
Inclusion Criteria:
- Age ≥ 22 years
- Diagnosis of a benign esophageal stricture with at least 2 previous dilations to at least 14mm within the last 12 months
- Target benign esophageal stricture etiologies include:
- Peptic stricture
- Schatzki's ring
- Stricture due to prior infection
- Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture
- Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy
Exclusion Criteria:
- 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, and purely radiation induced strictures (e.g. post head/neck cancer treatment)
- History of diagnosis of eosinophilic esophagitis (EoE)
Title: Paclitaxel Coated balloon for the Treatment of chronic bEnigN sTricture- Bowel
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Sponsor: GIE Medical.
Primary Investigator: Gregory Ginsberg, MD
CONTACT: Christine Gepty (christine.gepty@pennmedicine.upenn.edu or 215-349-8556)
Inclusion Criteria:
- 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
- Stricture length ≤ 5 cm
Exclusion Criteria:
- 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
- Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
- Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices
- Multiple clinically significant strictures separated by greater than 5 cm
- Received steroid injections into target stricture in the last 4 weeks