Barrett's Esophagus Clinical Trial
Official title:
Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus
Verified date | April 2019 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The specific aim of this study is to determine the feasibility of marking target pathologic locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of biopsy.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length - 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 anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure - 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 | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. | Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue. | day 1, during diagnostic procedure |
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