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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02947971
Other study ID # 2015-P000587
Secondary ID 5R01CA184102-02
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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