Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01439594
First received: September 20, 2011
Last updated: August 4, 2014
Last verified: August 2014

September 20, 2011
August 4, 2014
October 2008
March 2014   (final data collection date for primary outcome measure)
Feasibility and specificity of OFDI imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 mintues ] [ Designated as safety issue: No ]
Images will be analyzed and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques
Same as current
Complete list of historical versions of study NCT01439594 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Barrett's Esophagus
Device: MGH Optical Frequency Domain Imaging (OFDI) System
Imaging of Esophagus with OFDI system
Experimental: OFDI imaging
OFDI imaging
Intervention: Device: MGH Optical Frequency Domain Imaging (OFDI) System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01439594
2008-P-000793
No
Guillermo Tearney, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Guillermo Tearney, MD PhD Massachusetts General Hospital
Principal Investigator: Norman Nishioka, MD Massachusetts General Hospital
Massachusetts General Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP