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Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439035
First Posted: September 22, 2011
Last Update Posted: October 31, 2016
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.
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
  Purpose
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.

Condition Intervention Phase
Celiac Disease Device: MGH OFDI Imaging Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate Use of Optical Frequency Domain Imaging (OFDI) for Duodenal Imaging in Celiac Disease in Children, Adolescents and Young Adults

Resource links provided by NLM:


Further study details as provided by Guillermo Tearney, Massachusetts General Hospital:

Primary Outcome Measures:
  • Sensitivity and specificity of OFDI imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 mintues ]
    OFDI images will be analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions


Enrollment: 6
Study Start Date: August 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGH OFDI imaging
OFDI imaging
Device: MGH OFDI Imaging
Imaging of Duodenum with OFDI system

Detailed Description:

The Optical Frequency Domain Imaging(OFDI) catheter will be used in conjunction with a standard pediatric endoscope. The endoscopist will introduce the OFDI imaging catheter through the biopsy channel of the endoscope already in place. The catheter will be passed into the view of the endoscope so that the tip of the catheter can be directly visualized throughout the procedure. The catheter will be placed adjacent to the bowel wall in the vicinity of the target locations. Once the OFDI probe is in place, OFDI imaging will start and data will be continuously collected during helical pullback scanning of the inner catheter drive shaft over a predetermined length of approximately 3 cm.

It is expected that the total experimental procedure including the insertion of the OFDI catheter, OFDI imaging, and removal of the catheter will add approximately 10 minutes to the total length of the procedure.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439035


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Guillermo Tearney, MD PhD Massachusetts General Hospital
Principal Investigator: Aubrey Katz, MD Massachusetts General Hospital
  More Information

Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01439035     History of Changes
Other Study ID Numbers: 2009-P-000938
First Submitted: September 20, 2011
First Posted: September 22, 2011
Last Update Posted: October 31, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Celiac Disease
Duodenal
OCT
Imaging

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases