Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02445014
• Collaborator: National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 3
• Location: 1
• Arm: 1
• Actual Duration (Months): 63
• Patients Per Site Per Month: 0

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy; Barrett's Esophagus; Gastric Acid Reflux	Device: MGH SECM Imaging Capsule	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule
• Actual Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MGH SECM Imaging Capsule Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.	Device: MGH SECM Imaging Capsule; Imaging of the Esophagus using the SECM capsule and SECM Imaging system

Outcome Measures

Primary Outcome Measures

1. Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule. [20 minute visit (5-7 minute imaging)]

   The number of subjects from whom successful SECM imaging was obtained

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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
• National Institutes of Health (NIH)
• National Cancer Institute (NCI)

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, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02445014
• Other Study ID Numbers: 2014-P-002058; 1R01CA184102-01
• First Posted: May 15, 2015
• Last Update Posted: Aug 21, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Guillermo Tearney, Principal Investigator, Massachusetts General Hospital: Barrett's; GERD; Capsule; SECM
• Additional relevant MeSH terms: Barrett Esophagus; Gastroesophageal Reflux

Study Results

Participant Flow

Pre-assignment Detail	In this study we were trying to establish how many participants can provide us with quality imaging using this new technology. Therefore we treated them as one group. 2 healthy subjects and one with BE were enrolled. Upon reviewing imaging data it was concluded that this new technology is not optimal for the study and the enrollment was stopped.

Arm/Group Title	MGH SECM Imaging Capsule
Arm/Group Description	Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system. MGH SECM Imaging Capsule: Imaging of the Esophagus using the SECM capsule and SECM Imaging system
Period Title: Overall Study
STARTED	3
COMPLETED	3
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	MGH SECM Imaging Capsule
Arm/Group Description	Subject will swallow the new large SECM imaging capsule and images will be acquired using the SECM Imaging system.
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 33.3%
Male	2 66.7%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGH SECM Imaging Capsule
Arm/Group Description	Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system. MGH SECM Imaging Capsule: Imaging of the Esophagus using the SECM capsule and SECM Imaging system
Measure Participants	3
Count of Participants [Participants]	3 100%

Adverse Events

Time Frame	During the procedure and 10 minutes after
Arm/Group Title	MGH SECM Imaging Capsule
Arm/Group Description	Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system. The imaging quality will be reviewed.
All Cause Mortality
	MGH SECM Imaging Capsule
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Serious Adverse Events
	MGH SECM Imaging Capsule
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	MGH SECM Imaging Capsule
	Affected / at Risk (%)	# Events
Total	0/3 (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.