Status:

COMPLETED

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

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Celiac Disease

Eligibility:

All Genders

7+ years

Phase:

NA

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 evaluatio...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 4 2011

Estimated Enrollment :

6 Patients enrolled

Trial Details

Trial ID

NCT01439035

Start Date

August 1 2009

End Date

February 4 2011

Last Update

April 3 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114