N/A N=4

Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02947997 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule — 3 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: OFDI capsule (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule	3	—

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.

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.

View full record on ClinicalTrials.gov →

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.