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

NCT ID: NCT03670134

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2022-10-31

Brief Summary

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.

Detailed 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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Conditions

Barrett Esophagus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Volumetric laser Endomicroscopy (VLE)

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.

Group Type: EXPERIMENTAL

The Nvision VLE Imaging System

Intervention Type: DEVICE

Volumetric laser Endomicroscopy (VLE) will be performed by using the Nvision VLE Imaging System (Nine Point Medical, MA) consists of an imaging console, monitor and optical probe. The optical probe is centered by a balloon (diameter: 14 mm, 17 mm, 20 mm; length: 6 cm) that is deployed through a diagnostic gastroscope's instrument channel. Imaging is performed by automatic helical pullback of the probe from the distal to the proximal end of the balloon over 90 seconds.

Interventions

The Nvision VLE Imaging System

Volumetric laser Endomicroscopy (VLE) will be performed by using the Nvision VLE Imaging System (Nine Point Medical, MA) consists of an imaging console, monitor and optical probe. The optical probe is centered by a balloon (diameter: 14 mm, 17 mm, 20 mm; length: 6 cm) that is deployed through a diagnostic gastroscope's instrument channel. Imaging is performed by automatic helical pullback of the probe from the distal to the proximal end of the balloon over 90 seconds.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Cadman Leggett

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cadman L Leggett, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-003333

Identifier Type: -

Identifier Source: org_study_id