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

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439035
• Other study ID #: 2009-P-000938
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: February 4, 2011

Study information

• Verified date: April 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 4, 2011
• Est. primary completion date: February 4, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Device:
• MGH OFDI Imaging
Imaging of Duodenum with OFDI system

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging	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	during imaging session