Massachusetts General hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT02422433
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Marking and imaging of the esophagus using the OFDI Capsule and system.
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
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
The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.
Massachusetts General Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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