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Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

Primary Purpose

Barrett's Esophagus

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

About this trial

This is an interventional screening trial for Barrett's Esophagus focused on measuring SECM, Esophagus, Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A previous diagnosis of Barrett's Esophagus
  • Patients must be over the age of 18
  • Patient must be able to give informed consent

Exclusion Criteria:

  • Subjects with any history of intestinal strictures
  • OR subjects with a history of prior GI surgery
  • OR subjects with a history of intestinal Crohn's disease.

Sites / Locations

  • Massachusetts General hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SECM Probe Imaging

Arm Description

SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.

Outcomes

Primary Outcome Measures

Number of Participants With Tolerability of the Procedure
We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2014
Last Updated
April 1, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02210039
Brief Title
Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe
Official Title
Pilot Study to Image the Esophagus Using a SECM Probe
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE). Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.
Detailed Description
Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire. Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
SECM, Esophagus, Imaging

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SECM Probe Imaging
Arm Type
Experimental
Arm Description
SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.
Intervention Type
Device
Intervention Name(s)
SECM Probe
Intervention Description
Imaging of the esophagus using SECM probe and system.
Primary Outcome Measure Information:
Title
Number of Participants With Tolerability of the Procedure
Description
We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A previous diagnosis of Barrett's Esophagus Patients must be over the age of 18 Patient must be able to give informed consent Exclusion Criteria: Subjects with any history of intestinal strictures OR subjects with a history of prior GI surgery OR subjects with a history of intestinal Crohn's disease.
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

Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

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