Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2018 |
| Start Date: | September 2015 |
| End Date: | December 2015 |
The purpose of this study is to test the safety and feasibility of a redesigned tethered
capsule catheter that contains an integrated micro-motor. Investigators will be testing
imaging of this new technology in healthy volunteers.
capsule catheter that contains an integrated micro-motor. Investigators will be testing
imaging of this new technology in healthy volunteers.
10 healthy volunteers will be enrolled and asked to swallow the Distal Scanning Capsule. The
subjects will be awake and un-sedated.
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.
subjects will be awake and un-sedated.
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 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.
Exclusion Criteria:
- Subjects with the inability to swallow pills and capsules.
- Esophageal fistula and/or esophageal strictures with a stricture diameter that is
smaller than the diameter of the capsule.
- Subjects who have a bleeding disorder and are currently on anti-coagulants.
We found this trial at
1
site
Click here to add this to my saved trials
