DIGEST I Drug Coated Balloon for Biliary Stricture

Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture

DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on biliary tract stricture.

Up to 15 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.
2. Benign biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
3. Restenosis after plain balloon dilation with at least 2 previous balloon dilation sessions and recurrence of biliary obstructive symptoms/signs or being managed with implantable prosthetics (e.g. plastic stents).
4. Greater than 40% stenosis of the biliary tract via ERCP.
5. Total serum bilirubin >2 mg/dL. Alkaline phosphatase level >3 times higher than normal level. *Note: This IC is waved if the patient is being managed with implantable prosthetics.
6. Type I, II, III and IV Benign biliary duct strictures. Dominant stricture being accessible by balloon catheter.
7. Stricture length <4 cm.
8. Not currently listed for liver transplantation.
9. Voluntary participation and provided written informed consent.

Exclusion Criteria:

1. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
2. Benign biliary strictures caused by pancreatic pseudocyst compression.
3. Malignant biliary obstruction.
4. Biliary obstruction associated with an attack of acute pancreatitis.
5. Inability to pass guidewire across stricture.
6. Subjects with cholangitis or bile leak or duct fistula.
7. Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
8. Subject with an internal/external biliary drainage catheter.
9. Subjects with surgically altered gastro/duodenal/jejunal anatomy (e.g. Roux-Y-loop, choledochojejunostomy).
10. Subject with symptomatic duodenal stenosis (with gastric stasis)
11. Active systemic infection.
12. Allergy to paclitaxel or any components of the delivery system.
13. Currently undergoing required thoracic or abdominal cavity radiation therapy.
14. Has life expectancy <12 months.
15. Unwilling or unable to comply with the follow-up study requirements.
16. Lacking capacity to provide informed consent.
17. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
18. Currently participation in another pre-market drug or medical device clinical study.