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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MGH OFDI Imaging

Device

Imaging of Duodenum with OFDI system

Primary outcomes

Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging

Time frame: during imaging session

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Sep 22, 2011
Registry last updated: Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed