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

NCT02445027 | Completed Results FDA Device

• 1 other identifier: 2014-P001519
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Primary Care; Healthy

Outcome Measures

Primary Outcomes (1)

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

  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)

Study Arms (1)

MGH OCT Imaging Capsule

EXPERIMENTAL

Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system.

Device: MGH OCT Imaging Capsule

Interventions

MGH OCT Imaging Capsule DEVICE

Imaging of the esophagus using the OCT Capsule and system.

MGH OCT Imaging Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

• Title: Anna Gao RN.
• Organization: Massachusetts General Hospital

tearneylabtrials@partners.org

617-643-6092

Study Officials

• Guillermo Tearney, MD., PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: May 15, 2015
• Study Start: September 16, 2014
• Primary Completion: January 30, 2018
• Study Completion: March 18, 2020
• Last Updated: January 17, 2023
• Results First Posted: December 30, 2019

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)