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Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus

Primary Purpose

Eosinophilic Esophagitis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SECM Capsule
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eosinophilic Esophagitis focused on measuring SECM, Esophagus, Eosinophilic Esophagitis, Allergy

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject must be a healthy volunteer
  • OR subject must have a suspicion of EoE
  • OR subject must have a prior clinical suspicion of EoE
  • Subject must be older than 14 years of age
  • Subject must be able to give informed consent

Exclusion Criteria:

  • Subjects with the inability to swallow pills and capsules.
  • Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.

Sites / Locations

  • Massachusetts General hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging

Arm Description

Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.

Outcomes

Primary Outcome Measures

SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.
Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.
After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.

Secondary Outcome Measures

Full Information

First Posted
June 11, 2014
Last Updated
January 12, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02202590
Brief Title
Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus
Official Title
Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.
Detailed Description
72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked to swallow the SECM 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, multiple 2-dimensional cross sectional images of the esophagus are acquired. Images are analyzed at a later stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
SECM, Esophagus, Eosinophilic Esophagitis, Allergy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging
Arm Type
Experimental
Arm Description
Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.
Intervention Type
Device
Intervention Name(s)
SECM Capsule
Intervention Description
Imaging of the esophagus using the SECM capsule and system
Primary Outcome Measure Information:
Title
SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
Description
An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.
Time Frame
A single 20 minute visit (5-7 minute imaging).
Title
Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.
Description
After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.
Time Frame
Questionnaire adminstered directly after the imaging portion has been completed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject must be a healthy volunteer OR subject must have a suspicion of EoE OR subject must have a prior clinical suspicion of EoE Subject must be older than 14 years of age Subject must be able to give informed consent Exclusion Criteria: Subjects with the inability to swallow pills and capsules. Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
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

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Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus

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