Study to Image the Esophagus Using the OFDI Capsule

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02204150
• Collaborator: National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 56
• Location: 1
• Arm: 1
• Actual Duration (Months): 53
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus; Eosinophilic Esophagitis	Device: OFDI Capsule	N/A

Detailed Description

A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study for Imaging of the Esophagus Using an OFDI Capsule
• Actual Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jul 31, 2015
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OFDI Capsule Imaging Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.	Device: OFDI Capsule; Imaging of the esophagus using the OFDI Capsule and system

Outcome Measures

Primary Outcome Measures

1. Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule [Images will be acquired during the OFDI imaging session which should take an average of 5 minutes]

   Number of subjects from whom the quality OFDI imaging was obtained

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• A previous diagnosis of Barrett's Esophagus

• OR a previous diagnosis of EoE

• OR a previous diagnosis of Gastroesophageal reflux disease (GERD)

• Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE

• Subject must be able to give informed consent

Exclusion Criteria:

• Subjects with known esophageal strictures, intestinal strictures or dysphagia

• OR subjects with a history of prior GI surgery or GI 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
• 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: NCT02204150
• Other Study ID Numbers: 2011P002619; 5R01CA103769-07
• First Posted: Jul 30, 2014
• Last Update Posted: Apr 30, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Guillermo Tearney, Principal Investigator, Massachusetts General Hospital: Optical Coherence Tomography; Barrett's Esophagus; Esophagus; Imaging
• Additional relevant MeSH terms: Barrett Esophagus; Esophagitis; Eosinophilic Esophagitis

Study Results

Participant Flow

Pre-assignment Detail	In this feasibility study we try to establish the overall number of participants who are able to swallow the capsule and provide us with quality imaging using this new technology. At this point we do no distinguish tolerability separately in each of the three groups and are treating them as one.

Arm/Group Title	OFDI Capsule Imaging
Arm/Group Description	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
Period Title: Overall Study
STARTED	56
COMPLETED	56
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	OFDI Capsule Imaging
Arm/Group Description	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
Overall Participants	56
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	50 89.3%
>=65 years	6 10.7%
Sex: Female, Male (Count of Participants)
Female	18 32.1%
Male	38 67.9%
Region of Enrollment (Count of Participants)
United States	56 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
Description	Number of subjects from whom the quality OFDI imaging was obtained
Time Frame	Images will be acquired during the OFDI imaging session which should take an average of 5 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OFDI Capsule Imaging
Arm/Group Description	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
Measure Participants	56
Count of Participants [Participants]	56 100%

Adverse Events

Arm/Group Title	OFDI Capsule Imaging
Arm/Group Description	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system
All Cause Mortality
	OFDI Capsule Imaging
	Affected / at Risk (%)	# Events
Total	0/56 (0%)
Serious Adverse Events
	OFDI Capsule Imaging
	Affected / at Risk (%)	# Events
Total	0/56 (0%)
Other (Not Including Serious) Adverse Events
	OFDI Capsule Imaging
	Affected / at Risk (%)	# Events
Total	0/56 (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.