Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule
| Status: | Completed |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Healthy Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | April 2015 |
| End Date: | June 2017 |
Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule
The goal of this research is to test the feasibility and tolerability 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). This information will be used to assess optimal imaging technique, imaging quality,
and subject tolerability.
diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects,
subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease
(GERD). This information will be used to assess optimal imaging technique, imaging quality,
and subject tolerability.
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.
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.
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-2979
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