DIGEST I Drug Coated Balloon for Biliary Stricture

GIE Medical8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Biliary Stricture Biliary Anastomotic Stenosis Biliary Obstruction Biliary Disease

Interventions

GIE Drug Coated BalloonDEVICE

The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Adventista Hospital

Asunción, Paraguay

Outcomes

Primary Outcomes

Incident of serious balloon dilation-related complications

No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.

Time frame: 30 days

Freedom from Biliary Stricture Re-intervention

Biliary stricture re-intervention rate

Time frame: 12 months

Secondary Outcomes

Change in Liver Function

. Liver function tests include total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)

Time frame: Baseline, 7 days, 30 days, 3 months, 6 months, 12 months and 24 months

Change in Existing Biliary Obstructive Symptoms

The common biliary obstructive symptoms are right upper quadrant pain (survey), fever/chills (cholangitis), jaundice, itching, dark urine, pale stools, nausea/vomiting, weight loss

Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months

Biliary Stricture Diameter

Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP)

Time frame: Baseline, 6 months

Time to the First Re-intervention

The mean time to the first re-intervention (scheduled and unscheduled) will be assessed

Time frame: 12 months and 24 months

Sustained Clinical Success (SCS)

SCS defined as a period of at least 6 months with no need for further endoscopic intervention

Data from ClinicalTrials.gov

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