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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: MGH OCT Imaging Capsule

• Registration Number: NCT02445027
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2014-09-16
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Primary Completion: 2018-01-30
• Results First Submitted: 2019-11-07
• Results First Submitted QC: 2019-12-09
• Results First Posted: 2019-12-30
• Study Completion: 2020-03-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MGH OCT Imaging Capsule	MGH OCT Imaging Capsule	Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system.

Primary Outcome Measures

Name	Time	Method
Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.	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.

Trial Locations

Locations (1)

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