Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 4/5/2019 |
| Start Date: | August 2009 |
| End Date: | February 4, 2011 |
Pilot Study to Evaluate Use of Optical Frequency Domain Imaging (OFDI) for Duodenal Imaging in 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.
characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to
histologic evaluation in children, adolescents and young adults with suspected Celiac
disease.
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.
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.
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
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