Skip to main content
OpenTrials
Completed

NCT Number: NCT05263752

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Health System

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP with NvisionVLE® Imaging Low Profile System

Device

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

Primary outcomes

  1. Demographics- DOB

    Time frame: up to 2 years

    Date of birth

  2. Demographics- Sex

    Time frame: up to 2 years

    Male/Female

  3. Indication of Procedure

    Time frame: up to 2 years

    Anatomy Used: Biliary or Pancreatic

  4. Previous Surgical History

    Time frame: up to 2 years

    Stent type and Location

  5. Previous Imaging

    Time frame: up to 2 years

    Type of Imaging: CT or MRI for example

  6. Previous Procedures

    Time frame: up to 2 years

    EUS or ERCP

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.