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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

NCT02947971

Barrett's Esophagus

RECRUITING NA

Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting

NCT02445027

Healthy

COMPLETED NA

Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

NCT02422433

Barrett's Esophagus

ACTIVE_NOT_RECRUITING NA

Remote Manipulation of a Capsule Endoscope

NCT01044797

Healthy

COMPLETED

a/LCI-OCT Pilot in Esophagus

NCT04392167

Barrett Esophagus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

10 healthy volunteers will be enrolled and asked to swallow the Distal Scanning Capsule. The subjects will be awake and un-sedated.

The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OFDI capsule imaging

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.

OFDI capsule

Intervention Type DEVICE

Imaging of esophagus using OFDI capsule and system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OFDI capsule

Imaging of esophagus using OFDI capsule and system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes