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

M

Methodist Health System

Status

Completed

Conditions

Bile Duct Diseases

Treatments

Device: ERCP with NvisionVLE® Imaging Low Profile System

Study type

Observational

Funder types

Other

Identifiers

NCT05263752
059.GID.2017.D

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

3 participants in 1 patient group

Undergone ERCP with NvisionVLE® Imaging Low Profile System
Description:
Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019
Treatment:
Device: ERCP with NvisionVLE® Imaging Low Profile System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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