N/A
N=56
Study to Image the Esophagus Using the OFDI Capsule
Barrett's Esophagus · Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT02204150 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule — 56 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OFDI Capsule (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule |
56 | — |
Summary
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
Eligibility Criteria
Inclusion Criteria
- A previous diagnosis of Barrett's Esophagus
- OR a previous diagnosis of EoE
- OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
- Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
- Subject must be able to give informed consent
Exclusion Criteria
- Subjects with known esophageal strictures, intestinal strictures or dysphagia
- OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
Data sourced from ClinicalTrials.gov (NCT02204150). 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.