Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-03-02 @ 8:05 AM
Study NCT ID:
NCT01439594
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2011-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OFDI
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: