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OpenTrials
Completed

NCT Number: NCT02215291

NvisionVLE™ Registry System Registry

Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.

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Key information

Conditions

Esophagogastroduodenoscopy

Sex eligibility

All sexes

Study type

Observational

Primary location

Univeristy of South Alabama, Mobile, Alabama, United States

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About this study

This is a prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.

Up to 1000 patients from up to 20 sites nationwide.

There are no protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. A patient with a negative screening examination may not require additional screening endoscopies. For patients with established disease, further surveillance endoscopies will vary based on the extent of the disease (e.g. every 3 months, every 6 months, annual), which is based on the following American Society for Gastrointestinal Endoscopy (ASGE) guideline: the role of endoscopy in the surveillance of premalignant conditions of the upper GI tract. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients presenting for an endoscopic examination of the esophagus
  • Ability to provide written, informed consent to participate in the Registry

Exclusion criteria

  • Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU)

Treatment and study plan

Primary outcomes

  1. Percent of patients with endoscopically visible disease/ suspicious areas as determined by the physician

    Time frame: Baseline

    No protocol defined follow up visits. Patients will undergo an initial baseline Volumetric Laser Endomicroscopy (VLE) procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

  2. Percent of patients with VLE visible abnormalities/ suspicious areas as determined by the physician

    Time frame: Baseline

    No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

  3. Percent of patients with histologically confirmed disease and a breakdown of diseases observed

    Time frame: Baseline

    No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

  4. Percent of treated patients with endoscopic and VLE identified areas of retained or persistent abnormalities at the first endoscopic evaluation after treatment

    Time frame: Baseline

    No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

  5. Percent of treated patients undergoing surveillance with endoscopic and VLE areas of recurrent abnormality diagnosed by histology as disease

    Time frame: Baseline

    No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

  6. Percent of patients with abnormalities/ suspicious areas identified by the physician as subsquamous visualized on VLE and not seen on endoscopy

    Time frame: Baseline

    No protocol defined follow up visits. Patients will undergo an initial baseline VLE procedure. If patients have additional VLE procedures during the enrollment period, associated data will be collected.

Sponsors and collaborators

Lead sponsor

NinePoint Medical

Industry

Registry information

Official study title

High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging Registry

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Aug 13, 2014
Registry last updated
Mar 29, 2018

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.

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