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UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures

NCT04929821 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-29

No results posted yet for this study

Summary

STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY OBJECTIVES Clinical /Technical /Procedural success, Quality of Life improvement, biodegradation rate

Conditions

  • Biliary Obstruction
  • Bile Duct Stricture
  • Bile Duct Diseases

Interventions

DEVICE

Biliary Duct Stenting

UNITY-B Balloon-expandable Biodegradable Biliary Stent deployment in obstructed biliary ducts.

Sponsors & Collaborators

  • QualiMed Innovative Medizinprodukte GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Hong Kong
  • India
  • Malaysia

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 NCT04929821 on ClinicalTrials.gov