N/A Completed N=56 Diagnostic

Study to Image the Esophagus Using the OFDI Capsule

Barrett's esophagus · Eosinophilic Esophagitis

Source: ClinicalTrials.gov NCT02204150 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcomePrimary: Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule — 56 Participants

Summary

The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule	56	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.