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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439035
Other study ID # 2009-P-000938
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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