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

Mass General Brigham

Status: Completed

Conditions: Celiac Disease

Treatments: Device: MGH OFDI Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01439035

2009-P-000938

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

MGH OFDI imaging

Experimental group

Description:

OFDI imaging

Treatment:

Device: MGH OFDI Imaging