Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting
This trial is active, not recruiting.
|Treatment||mgh oct imaging capsule|
|Sponsor||Massachusetts General Hospital|
|Start date||August 2014|
|End date||September 2017|
|Trial size||20 participants|
|Trial identifier||NCT02445027, 2014-P001519|
The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system.
Feasibility of OCT Imaging in subjects swallowing the OCT capsule in the primary care setting
time frame: Approximate 20min visit (5min image acquisition)
Male or female participants at least 18 years old.
- Subjects must be scheduled for non-urgent appointment at primary care practice including annual wellness visits and routine follow-up appointments.
- Subjects must be over the age of 18
- Subjects must be able to give informed consent
- Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
- Subjects with current symptoms of dysphagia
- Subjects with any history of intestinal strictures, prior GI surgery, or history of intestinal Crohn's disease.
- Subjects with current symptoms of fever, nausea or sore throat at the time of the appointment.
|Official title||Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting|
|Principal investigator||Guillermo Tearney, MD., PhD|
|Description||20 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis. As the capsule progresses through the esophagus, multiple images of the esophagus are acquired and later analyzed.|
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