The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).
A total of 130 participants scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done. OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks. Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
130
Marking and imaging of the esophagus using the OFDI Capsule and system.
Massachusetts General hospital
Boston, Massachusetts, United States
Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
Time frame: It is expected that the total experimental time including swallowing the OFDI capsule OFDI, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes
Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
Time frame: It is expected that the total experimental time including swallowing the OFDI capsule OFDI, marking the region of interest, OFDI imaging, and removal of the OFDI capsule will take approximately 20 minutes
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