Back to resultsPilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule (SECM)
Primary Purpose
Healthy, Barrett's Esophagus, Gastric Acid Reflux
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MGH SECM Imaging Capsule
Sponsored by
About this trial
This is an interventional device feasibility trial for Healthy focused on measuring Barrett's, GERD, Capsule, SECM
Eligibility Criteria
Inclusion Criteria:
- Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).
- AND Subject must be able to give informed consent.
- AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.
Exclusion Criteria:
- Subjects with any history of or known upper gastrointestinal strictures
- OR Subjects with a history of Crohn's disease,
- OR Subjects with difficulty swallow
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MGH SECM Imaging Capsule
Arm Description
Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.
Outcomes
Primary Outcome Measures
Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
The number of subjects from whom successful SECM imaging was obtained
Secondary Outcome Measures
Full Information
NCT ID
NCT02445014
First Posted
April 16, 2015
Last Updated
August 11, 2020
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02445014
Brief Title
Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule
Acronym
SECM
Official Title
Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).
Detailed Description
36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Barrett's Esophagus, Gastric Acid Reflux
Keywords
Barrett's, GERD, Capsule, SECM
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MGH SECM Imaging Capsule
Arm Type
Experimental
Arm Description
Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.
Intervention Type
Device
Intervention Name(s)
MGH SECM Imaging Capsule
Intervention Description
Imaging of the Esophagus using the SECM capsule and SECM Imaging system
Primary Outcome Measure Information:
Title
Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
Description
The number of subjects from whom successful SECM imaging was obtained
Time Frame
20 minute visit (5-7 minute imaging)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).
AND Subject must be able to give informed consent.
AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.
Exclusion Criteria:
Subjects with any history of or known upper gastrointestinal strictures
OR Subjects with a history of Crohn's disease,
OR Subjects with difficulty swallow
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Tearney, MD., PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule
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