Status:
COMPLETED
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18+ years
Phase:
NA
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 associ...
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) abla...
Eligibility Criteria
Inclusion
- 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
- Patients on oral anticoagulation medications
- Patients with a history of hemostasis disorders
- Patients that are pregnant
- Patients with esophageal strictures
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01439594
Start Date
October 1 2008
End Date
March 1 2014
Last Update
November 22 2019
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114