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

January 12, 2023 updated by: Guillermo Tearney, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

60 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT capsule while being awake and unsedated. The capsule is attached to a 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 and later analyzed.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MGH OCT Imaging Capsule
Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system.
Device: MGH OCT Imaging Capsule
Imaging of the esophagus using the OCT Capsule and system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.
Time Frame: Approximate 20min visit (5min image acquisition)
Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis.
Approximate 20min visit (5min image acquisition)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Guillermo Tearney, MD., PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2014

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

March 18, 2020

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-P001519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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