N/A
N=60
Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02445027 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. — 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MGH OCT Imaging Capsule (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. |
45 | — |
Summary
The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.
Eligibility Criteria
Inclusion Criteria
- Subjects must be scheduled for non-urgent appointment at primary care practice including annual wellness visits and routine follow-up appointments.
- 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 current symptoms of dysphagia
- Subjects with any history of intestinal strictures, prior GI surgery, or history of intestinal Crohn's disease.
- Subjects with current symptoms of fever, nausea or sore throat at the time of the appointment.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02445027). 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.