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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

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE July 30, 2014
Results First Submitted Date  ICMJE March 28, 2019
Results First Posted Date  ICMJE April 23, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE February 2012
Actual Primary Completion Date July 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
  • Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes ]
    An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.
  • Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes ]
    After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Image the Esophagus Using the OFDI Capsule
Official Title  ICMJE Pilot Study for Imaging of the Esophagus Using an OFDI Capsule
Brief Summary The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Barrett's Esophagus
  • Eosinophilic Esophagitis
Intervention  ICMJE Device: OFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system
Study Arms  ICMJE Experimental: OFDI Capsule Imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
Intervention: Device: OFDI Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2019)
56
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2014)
54
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02204150
Other Study ID Numbers  ICMJE 2011P002619
5R01CA103769-07 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Guillermo Tearney, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Guillermo Tearney, MD., PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP