NvisionVLE™ Registry System Registry
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 4/17/2018 |
Start Date: | July 2014 |
End Date: | January 2018 |
High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging 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.
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.
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.
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.
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)
We found this trial at
18
sites
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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University of Southern California The University of Southern California is one of the world’s leading...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Phone: 603-650-5261
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Florida Hospital Florida Hospital is one of the country
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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