Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults
Pilot Study to Evaluate Use of Optical Frequency Domain Imaging (OFDI) for Duodenal Imaging in Celiac Disease in Children, Adolescents and Young Adults
1 other identifier
interventional
6
1 country
1
Brief Summary
The goal of this research is to conduct a pilot clinical study to image Celiac disease characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2011
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedResults Posted
Study results publicly available
September 26, 2018
CompletedApril 3, 2019
April 1, 2019
6 months
September 20, 2011
July 23, 2018
April 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging
OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions. In this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo
during imaging session
Study Arms (1)
MGH OFDI imaging
EXPERIMENTALOFDI imaging
Interventions
Eligibility Criteria
You may qualify if:
- Age 7 years and above undergoing upper endoscopy for evaluation of celiac disease
- Clinical history, physical findings, family history, or serologic evaluation suggestive of celiac disease
- Parents/guardian available to sign informed consent
You may not qualify if:
- Patients with a history of hemostasis disorders
- Use of Nonsteroidal anti-inflammatory drugs(NSAIDS) within ten days preceding initiation of the study
- Use of any oral anticoagulation medication within one month preceding initiation of the study
- Any known blood coagulation disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gary Tearney PI
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Tearney, MD PhD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Aubrey Katz, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pathology
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 22, 2011
Study Start
August 1, 2009
Primary Completion
February 4, 2010
Study Completion
February 4, 2011
Last Updated
April 3, 2019
Results First Posted
September 26, 2018
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share