Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

Barrett's Esophagus Clinical Trial

Official title:

Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02947971
• Other study ID #: 2015-P000587
• Secondary ID: 5R01CA184102-02
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2016
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Elizabeth Biddle, RN
• Phone: 617-643-6092
• Email: Tearneylabtrials[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Description:

Ten healthy volunteer subjects and ten volunteers with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.

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 peristalsis.

Images of the esophagus will be acquired in real time to be analyzed later.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)

• Subjects must be over the age of 18 but less than 70 year of age.

• 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 over 70 years of age

• Subjects with the inability to swallow pills and capsules.

• Subjects with a strong gag reflex

• Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.

• Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• Experimental OFDI Imaging
Imaging of the esophagus with a compact OFDI system and distal scanning catheter

Locations

Country	Name	City	State
United States	Massachusetts General hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of quality and performance of Compact Imaging System (CIS)	Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system	5-7 Minutes of imaging