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Study to Image the Esophagus Using the OFDI Capsule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204150
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : April 23, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Barrett's Esophagus
Eosinophilic Esophagitis
Intervention Device: OFDI Capsule
Enrollment 56
Recruitment Details  
Pre-assignment Details 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
Hide 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
Arm/Group Title OFDI Capsule Imaging
Hide 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 Number of Baseline Participants 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
<=18 years
0
   0.0%
Between 18 and 65 years
50
  89.3%
>=65 years
6
  10.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
18
  32.1%
Male
38
  67.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 56 participants
56
 100.0%
1.Primary Outcome
Title Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OFDI Capsule Imaging
Hide 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 Number of Participants Analyzed 56
Measure Type: Count of Participants
Unit of Measure: Participants
56
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OFDI Capsule Imaging
Hide 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 (%)
Total   0/56 (0.00%) 
Hide Serious Adverse Events
OFDI Capsule Imaging
Affected / at Risk (%)
Total   0/56 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
OFDI Capsule Imaging
Affected / at Risk (%)
Total   0/56 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary Tearney
Organization: Mass General Hospital
Phone: 617-724-2979
EMail: gtearney@partners.org
Layout table for additonal information
Responsible Party: Guillermo Tearney, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02204150    
Other Study ID Numbers: 2011P002619
5R01CA103769-07 ( U.S. NIH Grant/Contract )
First Submitted: June 12, 2014
First Posted: July 30, 2014
Results First Submitted: March 28, 2019
Results First Posted: April 23, 2019
Last Update Posted: April 30, 2019