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
  Purpose

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.


Condition Intervention Phase
Barrett's Esophagus
Device: MGH Optical Frequency Domain Imaging (OFDI) System
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 17
Study Start Date: October 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OFDI imaging
OFDI imaging
Device: MGH Optical Frequency Domain Imaging (OFDI) System
Imaging of Esophagus with OFDI system

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439594

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Guillermo Tearney, MD PhD Massachusetts General Hospital
Principal Investigator: Norman Nishioka, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01439594     History of Changes
Other Study ID Numbers: 2008-P-000793
Study First Received: September 20, 2011
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Barrett's Esophagus
Esophagus
OCT
Imaging
Radiofrequency Ablation
BARRX

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 29, 2014