NCT02688114

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 18, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2020

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

February 11, 2016

Last Update Submit

September 7, 2023

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

  • Change in the Percent of Mucosa Healed by Neosquamous Epithelium

    % of the esophageal mucosa healed by Neosquamous epithelium at 1 week, 2 weeks, and 4 weeks after RFA

    1 week, 2 weeks, 4 weeks

Secondary Outcomes (2)

  • Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands

    1 week, 2 weeks, 4 weeks

  • Change in inflammatory cell infiltrate

    1 week, 2 weeks, 4 weeks

Study Arms (1)

Barrett's Esophagus Treatment

EXPERIMENTAL

All participants are in the treatment arm. Patients with Barrett's esophagus will undergo baseline surveillance endoscopy, be treated with radiofrequency ablation, and undergo follow up endoscopy 1, follow up endoscopy 2, and follow up endoscopy 3.

Procedure: Baseline surveillance endoscopyProcedure: Radiofrequency ablationProcedure: Follow up endoscopy 1Procedure: Follow up endoscopy 2Procedure: Follow up endoscopy 3

Interventions

Baseline surveillance endoscopyPROCEDURE

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

Barrett's Esophagus Treatment
Radiofrequency ablationPROCEDURE

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

Barrett's Esophagus Treatment
Follow up endoscopy 1PROCEDURE

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

Barrett's Esophagus Treatment
Follow up endoscopy 2PROCEDURE

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

Barrett's Esophagus Treatment
Follow up endoscopy 3PROCEDURE

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

Barrett's Esophagus Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Barrett's esophagus

You may not qualify if:

  • inability to provide informed consent
  • esophageal varices
  • treatment with warfarin
  • coagulopathy that precludes safe biopsy of the esophagus (including platelet count \<100,000/mm3, INR (international normalized ratio) \>1.5)
  • allergy to fluorescein sodium
  • comorbidity that precludes safe participation in the study
  • pregnancy or breastfeeding status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor Scott and White Research Institute

Dallas, Texas, 75204, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Stuart J Spechler, MD

    Baylor Scott and White Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Gastroenterology

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 23, 2016

Study Start

October 18, 2017

Primary Completion

January 29, 2020

Study Completion

January 29, 2020

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)