N/A
Completed N=4
Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning
Healthy
Source: ClinicalTrials.gov NCT02947997 ↗
Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule — 3 Participants
Summary
The purpose of this study is to test 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule |
3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02947997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.