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

Completed

• Conditions: Healthy
• Interventions: Device: OFDI capsule

• Registration Number: NCT02947997
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2015-09
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Results First Submitted: 2018-07-20
• Results First Submitted QC: 2019-10-24
• Results First Posted: 2019-11-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States