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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02210039
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Device: SECM Probe	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Pilot Study to Image the Esophagus Using a SECM Probe
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SECM Probe Imaging SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.	Device: SECM Probe; Imaging of the esophagus using SECM probe and system.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Tolerability of the Procedure [During 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Guillermo Tearney, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02210039
• Other Study ID Numbers: 2013-P-001213
• First Posted: Aug 6, 2014
• Last Update Posted: Apr 3, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital: SECM; Esophagus; Imaging
• Additional relevant MeSH terms: Barrett Esophagus

Study Results

Participant Flow

Arm/Group Title	SECM Probe Imaging
Arm/Group 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. SECM Probe: Imaging of the esophagus using SECM probe and system.
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	SECM Probe Imaging
Arm/Group 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. SECM Probe: Imaging of the esophagus using SECM probe and system.
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 66.7%
>=65 years	2 33.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.16 (12.20)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	6 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All six study participants completed the study and the obtained data has been analyzed

Arm/Group Title	SECM Probe Imaging
Arm/Group 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. SECM Probe: Imaging of the esophagus using SECM probe and system.
Measure Participants	6
Count of Participants [Participants]	6 100%

Adverse Events

Time Frame	During the procedure
Adverse Event Reporting Description	The adverse events were collected systematically for this study. The definition of adverse events is the same as clinicaltrials.gov definition.
Arm/Group Title	SECM Probe Imaging
Arm/Group 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. SECM Probe: Imaging of the esophagus using SECM probe and system. No adverse events has been reported.
All Cause Mortality
	SECM Probe Imaging
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	SECM Probe Imaging
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	SECM Probe Imaging
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.