N/A
Completed N=6
Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults
Source: ClinicalTrials.gov NCT01439035 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging — 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging |
6 | — |
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
Data sourced from ClinicalTrials.gov (NCT01439035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.