Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

Not Applicable

Completed

• Conditions: Barrett's Esophagus
• Interventions: Device: MGH OFDI Imaging

• Registration Number: NCT01439594
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.

Detailed Description

This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.

Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (\~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.

Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-23
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2019-07-31
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Results First Posted: 2019-11-22
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Patients with a diagnosis of Barrett's esophagus
• Patients undergoing an Esophagogastroduodenoscopy (EGD)
• Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation
• Patients must be over the age of 18
• Patient must be able to give informed consent
• Women with child bearing potential must have a negative pregnancy test prior to procedure

Exclusion Criteria

• Patients on oral anticoagulation medications
• Patients with a history of hemostasis disorders
• Patients that are pregnant
• Patients with esophageal strictures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MGH OFDI Imaging	MGH OFDI Imaging	OFDI imaging

Primary Outcome Measures

Name	Time	Method
Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions	During the OFDI imaging session (about 5 minutes)	Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States