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DIGEST I Drug Coated Balloon for Biliary Stricture

NCT03997994 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-08-17

No results posted yet for this study

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

Interventions

DEVICE

GIE Drug Coated Balloon

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

Sponsors & Collaborators

  • GIE Medical

    lead INDUSTRY

Principal Investigators

  • Bret T Petersen, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-12
Primary Completion
2024-03-21
Completion
2025-03-21
FDA Device
Yes

Countries

  • Paraguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997994 on ClinicalTrials.gov