DIGEST I Drug Coated Balloon for Biliary Stricture

NCT03997994 | Unknown FDA Device

• 1 other identifier: PR 2002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Stricture; Biliary Anastomotic Stenosis; Biliary Obstruction; Biliary Disease

Outcome Measures

Primary Outcomes (2)

• Incident of serious balloon dilation-related complications

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

  30 days

• Freedom from Biliary Stricture Re-intervention

  Biliary stricture re-intervention rate

  12 months

Secondary Outcomes (8)

• Change in Liver Function

  Baseline, 7 days, 30 days, 3 months, 6 months, 12 months and 24 months

• Change in Existing Biliary Obstructive Symptoms

  Baseline, 30 days, 3 months, 6 months, 12 months and 24 months

• Biliary Stricture Diameter

  Baseline, 6 months

• Time to the First Re-intervention

  12 months and 24 months

• Sustained Clinical Success (SCS)

  12 months and 24 months

Study Arms (1)

Experimental: DCB Treatment

EXPERIMENTAL

Stricture patients treated by DCB

Device: GIE Drug Coated Balloon

Interventions

GIE Drug Coated Balloon DEVICE

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

Experimental: DCB Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 80 years.
• Benign biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
• 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).
• Greater than 40% stenosis of the biliary tract via ERCP.
• 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.
• Type I, II, III and IV Benign biliary duct strictures. Dominant stricture being accessible by balloon catheter.
• Stricture length \<4 cm.
• Not currently listed for liver transplantation.
• Voluntary participation and provided written informed consent.

You may not qualify if:

• Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
• Benign biliary strictures caused by pancreatic pseudocyst compression.
• Malignant biliary obstruction.
• Biliary obstruction associated with an attack of acute pancreatitis.
• Inability to pass guidewire across stricture.
• Subjects with cholangitis or bile leak or duct fistula.
• Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
• Subject with an internal/external biliary drainage catheter.
• Subjects with surgically altered gastro/duodenal/jejunal anatomy (e.g. Roux-Y-loop, choledochojejunostomy).
• Subject with symptomatic duodenal stenosis (with gastric stasis)
• Active systemic infection.
• Allergy to paclitaxel or any components of the delivery system.
• Currently undergoing required thoracic or abdominal cavity radiation therapy.
• Has life expectancy \<12 months.
• Unwilling or unable to comply with the follow-up study requirements.

Sponsors & Collaborators

• GIE Medical: lead

Study Sites (1)

Adventista Hospital

Asunción, Paraguay

Location

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Bret T Petersen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: May 12, 2019
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2025
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

PA (1)