Barrett's Esophagus Clinical Trial
Official title:
Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction
Verified date | January 2023 |
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 accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .
Status | Completed |
Enrollment | 109 |
Est. completion date | November 16, 2011 |
Est. primary completion date | November 16, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - over the age of 18, - capable of giving informed consent, - are undergoing elective EGD, and - if female are willing to take a pregnancy test Exclusion Criteria: - patients on oral anticoagulation medications, - with a history of hemostasis disorders and - patients that are pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Massachussetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening | Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy. | Images will be acquired during the OFDI imaging session which should take an average of 5 minutes |
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