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

Primary Purpose

Celiac Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MGH OFDI Imaging

About this trial

This is an interventional diagnostic trial for Celiac Disease focused on measuring Celiac Disease, Duodenal, OCT, Imaging

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MGH OFDI imaging

Arm Description

OFDI imaging

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01439035

First Posted

September 20, 2011

Last Updated

April 1, 2019

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01439035

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

February 4, 2010 (Actual)

Study Completion Date

February 4, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Celiac Disease

Keywords

Celiac Disease, Duodenal, OCT, Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MGH OFDI imaging

Arm Type

Experimental

Arm Description

OFDI imaging

Intervention Type

Device

Intervention Name(s)

MGH OFDI Imaging

Intervention Description

Imaging of Duodenum with OFDI system

Primary Outcome Measure Information:

Title

Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging

Description

Time Frame

during imaging session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillermo Tearney, MD PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Aubrey Katz, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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