Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
Study Overview
Brief Summary
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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
MGH SECM Imaging Capsule
Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.
Intervention: MGH SECM Imaging Capsule (Device)
Outcomes
Primary Outcomes
Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
Time Frame: 20 minute visit (5-7 minute imaging)
The number of subjects from whom successful SECM imaging was obtained
Secondary Outcomes
No secondary outcomes reported
Investigators
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital