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This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and the second generation of colon capsule in comparison second generation of colon capsule endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast ultrasonography (SICUS) and endoscopy (upper and lower).
This study aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCE-2 | Experimental | Second generation of Colon capsule endoscopy in pediatric Crohn's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second generation of colon capsule endoscopy (GIVEN IMAGING) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate and compare the accuracy of Second generation of Colon Capsule Endoscopy with magnetic resonance enterography, small intestine contrast ultrasonography and endoscopy in the evaluation of pediatric Crohn's disease. | Accuracy parameters (sensitivity, specificity, NPV, PPV) of second generation of colon capsule endoscopy compared to endoscopy, to magnetic resonance enterography and to small intestine contrast ultrasonography in evaluating disease activity in pediatric CD. The disease activity will be evaluated with a validated score (SES-CD) for endoscopy and imaging tool (damage-score). | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease. | Number, type and severity of adverse events with second generation of Crohn's disease. | two days |
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Ages Eligible for Study: 6-18 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Inclusion criteria:
Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:
Exclusion criteria
The presence of any of the following will exclude a subject from study enrollment:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome | Rome | Rome | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26363334 | Derived | Oliva S, Cucchiara S, Civitelli F, Casciani E, Di Nardo G, Hassan C, Papoff P, Cohen SA. Colon capsule endoscopy compared with other modalities in the evaluation of pediatric Crohn's disease of the small bowel and colon. Gastrointest Endosc. 2016 May;83(5):975-83. doi: 10.1016/j.gie.2015.08.070. Epub 2015 Sep 9. |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| D013514 | Surgical Procedures, Operative |