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NvisionVLE™ Registry System Registry

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ClinicalTrials.gov Identifier: NCT02215291
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
NinePoint Medical

Brief Summary:
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.

Condition or disease
Esophagogastroduodenoscopy

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging Registry
Study Start Date : July 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : January 2018

Group/Cohort
Patients undergoing EGD or esophagoscopy
The cohort includes patients undergoing EGD or esophagoscopy for initial diagnosis or initial staging and mapping, surveillance of non-treated disease, and treatment (initial or ongoing) or post-treatment surveillance



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 20 sites; each site will have the opportunity to enroll up to 100 patients. There will be up to 1000 patients enrolled in the registry.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215291


Locations
Show Show 18 study locations
Sponsors and Collaborators
NinePoint Medical
Investigators
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Principal Investigator: Michael Smith, MD, MBA Temple University Hospital

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NinePoint Medical
ClinicalTrials.gov Identifier: NCT02215291    
Other Study ID Numbers: 13_02
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Keywords provided by NinePoint Medical:
Undergoing Esophagogastroduodenoscopy (EGD) or endoscopy