Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2014-07-31
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Ability to provide written, informed consent to participate in the Registry
Exclusion Criteria
ALL
No
Sponsors
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NinePoint Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Smith, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Temple University Hospital
Locations
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Univeristy of South Alabama
Mobile, Alabama, United States
University of Southern California
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Ochsner Health System
Kenner, Louisiana, United States
VA Boston Health Care System
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
North Shore/ LIJ
Long Island City, New York, United States
Weill Cornell Medical College/NewYork-Presbyterian Hospital
New York, New York, United States
Columbia Univeristy
New York, New York, United States
Geisinger
Danville, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Countries
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References
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Smith MS, Cash B, Konda V, Trindade AJ, Gordon S, DeMeester S, Joshi V, Diehl D, Ganguly E, Mashimo H, Singh S, Jobe B, McKinley M, Wallace M, Komatsu Y, Thakkar S, Schnoll-Sussman F, Sharaiha R, Kahaleh M, Tarnasky P, Wolfsen H, Hawes R, Lipham J, Khara H, Pleskow D, Navaneethan U, Kedia P, Hasan M, Sethi A, Samarasena J, Siddiqui UD, Gress F, Rodriguez R, Lee C, Gonda T, Waxman I, Hyder S, Poneros J, Sharzehi K, Di Palma JA, Sejpal DV, Oh D, Hagen J, Rothstein R, Sawhney M, Berzin T, Malik Z, Chang K. Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry. Dis Esophagus. 2019 Nov 13;32(9):doz029. doi: 10.1093/dote/doz029.
Other Identifiers
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13_02
Identifier Type: -
Identifier Source: org_study_id
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