MedDataX Logo

WallFlex Biliary Post Liver Transplant IDE Pilot

NCT ID: NCT01151280

Last Updated: 2013-12-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WallFlex Biliary Fully Covered Stent

All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent

Group Type EXPERIMENTAL

WallFlex Biliary Fully Covered Stent

Intervention Type DEVICE

Investigational device evaluated for the treatment for benign biliary strictures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WallFlex Biliary Fully Covered Stent

Investigational device evaluated for the treatment for benign biliary strictures

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 or older
2. Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by:

* Clinical signs and symptoms including jaundice, abdominal pain, pruritis, and cholangitis
* Abnormal liver function tests (serum bilirubin \> 1.5 and/or elevated alkaline phosphatase levels)
* Abnormal imaging on ultrasound, CT scan, or MRCP suggestive of a biliary stricture
3. Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria

1. Roux-en-Y choledochojejunostomy
2. Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis)
3. Living donor transplants
4. Transplants performed within 30 days (fresh transplants)
5. Perforation of any duct within the biliary tree
6. Patients with known sensitivity to any components of the stent or delivery system
7. Patients with malignancy involving the biliary tree (including hepatocellular carcinoma)
8. Patients with poor Karnofsky score
9. Life expectancy of less than one year
10. Inability to pass a guidewire through the strictured area
11. Previous biliary metal or multiple plastic stent placement
12. Drug-induced or cholestatic hepatitis from an infective cause
13. Redundant bile duct that may be treated by temporary placement of stent or conversion to a RouxEnY hepaticojejunostomy
14. Choledocholithiasis/biliary "cast" syndrome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Divyesh Sejpal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mount Sinai Medical Center

New York, New York, United States

Site Status

Mansour Parsi, MD

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E7055

Identifier Type: OTHER

Identifier Source: secondary_id

E7055

Identifier Type: -

Identifier Source: org_study_id