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Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus

NCT02688114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-09-11

No results posted yet for this study

Summary

Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus.

Conditions

  • Barrett Esophagus

Interventions

PROCEDURE

Baseline surveillance endoscopy

All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.

PROCEDURE

Radiofrequency ablation

All study participants will undergo radiofrequency ablation of Barrett's esophagus

PROCEDURE

Follow up endoscopy 1

All study participants will undergo follow up endoscopy 1 week after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.

PROCEDURE

Follow up endoscopy 2

All study participants will undergo follow up endoscopy 2 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.

PROCEDURE

Follow up endoscopy 3

All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.

Sponsors & Collaborators

  • Dallas VA Medical Center

    lead FED

Principal Investigators

  • Stuart J Spechler, MD · Baylor Scott and White Research Institute

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2020-01-29
Completion
2020-01-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02688114 on ClinicalTrials.gov