Barrett's Esophagus Clinical Trial
— OFDIOfficial title:
Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation
NCT number | NCT01439594 |
Other study ID # | 2008-P000793 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2008 |
Est. completion date | March 2014 |
Verified date | November 2019 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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) |
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