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

Completed

• Conditions: Bile Duct Diseases
• Interventions: Device: ERCP with NvisionVLE® Imaging Low Profile System

• Registration Number: NCT05263752
• Lead Sponsor: Methodist Health System

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-10-18
• Study First Submitted: 2019-08-12
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Undergone ERCP with NvisionVLE® Imaging Low Profile System	ERCP with NvisionVLE® Imaging Low Profile System	Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019

Primary Outcome Measures

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

Trial Locations

Locations (1)

Methodist Health System; 🇺🇸 Dallas, Texas, United States