NCT04929821

Brief 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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
3 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

6.1 years

First QC Date

August 20, 2020

Last Update Submit

March 28, 2023

Conditions

Biliary ObstructionBile Duct StrictureBile Duct Diseases

Outcome Measures

Primary Outcomes (1)

  • Safety Complication Rate for the first 30days

    Total number of all complications is calculated as aggregate for the duration 30 days (day zero till day30 after index procedure). Two-sided 95% confidence intervals is constructed using exact (Clopper-Pearson) method.

    30 days

Secondary Outcomes (2)

  • Efficacy Rates of Clinical Success

    365days

  • Efficacy Rates of Technical Success

    365days

Study Arms (1)

Study Device Treated Group

OTHER

Treated with the study device, UNITY-B Biodegradable Balloon-Expandable Biliary Stent System.

Device: Biliary Duct Stenting

Interventions

Biliary Duct StentingDEVICE

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

Study Device Treated Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) A subject with a biliary stricture may be entered into the study with: at least one of the following:
  • Benign fibrotic distal bile duct obstruction
  • Duct occlusion caused by cholelithiasis
  • A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance cholangiopancreatography (MRCP) and/or ERCP with proximal ductal dilation and cholestatic liver enzymes levels
  • Ductal anastomotic strictures
  • Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla.
  • Neoplasm diagnosed on clinical and imaging findings
  • Post-ERCP pancreatitis
  • Obstructive jaundice with evidence of pruritus, tea color urine and pale stool
  • Abnormal Bilirubin rate or
  • A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or
  • A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old

You may not qualify if:

  • Patients, male or female, presenting with the following criteria may be included:
  • Subject is unwilling to comply with the follow-up schedule
  • Life expectancy \< 12 m,
  • Inability to pass a guidewire through stricture
  • Contra-indication for endoscopy or interventional radiology
  • History of allergic reactions to one of the compounds of investigational product.
  • Subject is unable or refuses to give informed consent
  • Subject is pregnant or breastfeeding
  • Patient under tutorship
  • Currently participating in another trial before reaching first endpoint.
  • Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma
  • Patient need additional biliary stenting with another device than the study device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

The Prince of Wales Hospital

Hong Kong, Hong Kong

ENROLLING BY INVITATION

AIG Hospitals (Asian Institute of Gastroenterology)

Hyderabad, 500032, India

RECRUITING

Sunway Medical Centre

Kuala Lumpur, 47500, Malaysia

RECRUITING

Universityi Kebangsaan Malaysia (UKM)

Kuala Lumpur, 56000, Malaysia

COMPLETED

University Malaya Medical Centre (UMMC)Clinical Investigation Centre (CIC)

Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Central Study Contacts

Hairol Azrin bin Othman, MD

CONTACT

60374919191hairol@gmail.com

Edwin Tan

CONTACT

60374911226edwinbt@sunway.com.my

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

August 20, 2020

First Posted

June 18, 2021

Study Start

October 16, 2017

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)MY(3)IN(1)