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

NCT ID: NCT01439035

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-02-04

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.

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.

Conditions

Celiac Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MGH OFDI imaging

OFDI imaging

Group Type: EXPERIMENTAL

MGH OFDI Imaging

Intervention Type: DEVICE

Imaging of Duodenum with OFDI system

Interventions

MGH OFDI Imaging

Imaging of Duodenum with OFDI system

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Tearney

Professor of Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Tearney, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Aubrey Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2009-P-000938

Identifier Type: -

Identifier Source: org_study_id