DIGEST I Pilot Study (DIGEST) (DIGEST)
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|ClinicalTrials.gov Identifier: NCT03997994|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Biliary Stricture Biliary Anastomotic Stenosis Biliary Obstruction Biliary Disease||Device: GIE Drug Coated Balloon||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture|
|Actual Study Start Date :||May 12, 2019|
|Estimated Primary Completion Date :||March 21, 2021|
|Estimated Study Completion Date :||March 21, 2025|
Experimental: Experimental: DCB Treatment
Stricture patients treated by DCB
Device: GIE Drug Coated Balloon
The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers.
- Incident of serious balloon dilation-related complications [ Time Frame: 30 days ]No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.
- Freedom from Biliary Stricture Re-intervention [ Time Frame: 12 months ]Biliary stricture re-intervention rate
- Change in Liver Function [ Time Frame: 7 days, 30 days, 3 months, 6 months, 12 months and 24 months ]. Liver function tests include total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)
- Change in Existing Biliary Obstructive Symptoms [ Time Frame: 30 days, 3 months, 6 months, 12 months and 24 months ]The common biliary obstructive symptoms are right upper quadrant pain (survey), fever/chills (cholangitis), jaundice, itching, dark urine, pale stools, nausea/vomiting, weight loss
- Biliary Stricture Diameter [ Time Frame: 6 months ]Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP)
- Time to the First Re-intervention [ Time Frame: 12 months and 24 months ]The mean time to the first re-intervention (scheduled and unscheduled) will be assessed
- Sustained Clinical Success (SCS) [ Time Frame: 12 months and 24 months ]SCS defined as a period of at least 6 months with no need for further endoscopic intervention
- Long Term Clinical Success (LTCS) [ Time Frame: 12 months and 24 months ]LTCS, defined as no need for further endoscopic intervention for at least 24 months
- Mean number of dilations [ Time Frame: 12 months and 24 months ]Mean number of dilations required to achieve SCS and LTCS
- Technical Success [ Time Frame: 0 months ]Technical success is defined as successful insertion, dilatation of the target biliary stricture, and finally withdrawal of the device with no device malfunctions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997994
|Contact: Peter J Barnett, MSfirstname.lastname@example.org|
|Contact: Carlos A Cetraro 0981 524 485 email@example.com|
|Principal Investigator:||Bret T Petersen, MD||Mayo Clinic|