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NCT05263752 Clinical Trial

Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease

Bile Duct Diseases Clinical Trial

Official title:
Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05263752
Other study ID # 059.GID.2017.D
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 18, 2017
Est. completion date June 30, 2020

Study information
Verified date February 2022
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A previous study evaluating the NvisionVLE® Imaging Low Profile System revealed the system to be feasible and safe for use in bile duct. The study also revealed a potential to better define abnormalities, target sampling and therapy when utilizing the NvisionVLE® Imaging Low Profile System. This study will further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct diseases.

Description:

The primary objective of this retrospective and prospective study is to acquire additional data to further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct disease. The secondary objective will be to provide a tool for participating physicians to collect imaging data, clinical utility data, and other clinical data such as demographics, pathology, and treatment surveillance results for patients who have undergone an examination of the bile duct with the NvisionVLE® Imaging Low Profile System. Specific aims include completing a multi-center registry to further evaluate the safety and efficacy of the NvisionVLE® Imaging System Low Profile System and developing a tool from the NvisionVLE® Imaging Low Profile System data to better define abnormalities, target sampling and therapy in patients with bile duct disease.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or older - Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019. Exclusion Criteria: - Below 18 years of age - Did not undergo ERCP with NvisionVLE® Imaging Low Profile System at MDMC

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ERCP with NvisionVLE® Imaging Low Profile System
Endoscopic Retrograde Cholangio-Pancreatography (ERCP) with NvisionVLE® Imaging Low Profile System

Locations
Country Name City State
United States Methodist Health System Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Demographics- DOB Date of birth up to 2 years
Primary Demographics- Sex Male/Female up to 2 years
Primary Indication of Procedure Anatomy Used: Biliary or Pancreatic up to 2 years
Primary Previous Surgical History Stent type and Location up to 2 years
Primary Previous Imaging Type of Imaging: CT or MRI for example up to 2 years
Primary Previous Procedures EUS or ERCP up to 2 years
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