Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule
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About
The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).
Full description
36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated.
The capsule is attached to a string like 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 in real time to be analyzed later.
Enrollment
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Volunteers
Inclusion criteria
- Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).
- AND Subject must be able to give informed consent.
- AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.
Exclusion criteria
- Subjects with any history of or known upper gastrointestinal strictures
- OR Subjects with a history of Crohn's disease,
- OR Subjects with difficulty swallow
Trial design
Primary purpose
Allocation
Interventional model
Masking
3 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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