Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

Barrett's Esophagus Clinical Trial

— OFDI  

Official title:

Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439594
• Other study ID #: 2008-P000793
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: March 2014

Study information

• Verified date: November 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• MGH OFDI Imaging
Imaging of Esophagus with OFDI system

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions	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.	During the OFDI imaging session (about 5 minutes)