Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia

Mayo Clinic

Status: Withdrawn

Conditions: Barrett Esophagus

Treatments: Device: The Nvision VLE Imaging System

Study type: Interventional

Funder types: Other

Identifiers

NCT03670134

18-003333

Details and patient eligibility

About

Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.

Full description

Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. At each follow-up visit, endoscopic data will be collected to determine if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2).

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Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.
• Ability to provide written, informed consent
• No significant esophagitis (LA grade <B, C, and D)

Exclusion criteria

• Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
• Prior esophageal or gastric surgical resection
• Significant esophageal stricture requiring dilatation
• Patients who require anti-coagulation for who biopsy would be contraindicated
• Patients who are known to be pregnant

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Volumetric laser Endomicroscopy (VLE)

Experimental group

Description:

Volumetric laser Endomicroscopy (VLE) is a second-generation optical coherence tomography platform that can image the human esophagus in cross-section at microscopic resolution this will performed by using the Nvision VLE Imaging System.

Treatment:

Device: The Nvision VLE Imaging System