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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: OFDI capsule

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy Volunteers

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OFDI capsule imaging; Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.	Device: OFDI capsule; Imaging of esophagus using OFDI capsule and system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule	An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed	Approximate 20 minute visit (5 min image acquisition)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 28, 2016

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: Healthy Volunteers
• Other Study ID Numbers: 2015-P000777

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