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This prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy.
This study aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 children with UC | This prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate and compare the accuracy of PillCam ⢠Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. | Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy in pediatric Ulcerative Colitis. | Day 3 (after colonoscopy and CCE-2) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of PillCam ⢠Colon capsule endoscopy (PCCE) in pediatric age. | Number, type and severity of adverse events with both PCCE and standard colonoscopy | Day 3 (after colonoscopy and CCE-2) |
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ELIGIBILITY 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:
The presence of any of the following will exclude a subject from study enrollment:
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The GivenĀ® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the GivenĀ® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure. This prospective pilot study will evaluate the performance of PCCE in visualizing the colon of children with UC. All subjects to be enrolled will be appropriate candidates for standard colonoscopy based on their clinical indication.
Each subject will undergo PCCE. PCCE results will be compared with that of a colonoscopy procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza - University of Rome | Rome | Italy | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24777427 | Derived | Oliva S, Di Nardo G, Hassan C, Spada C, Aloi M, Ferrari F, Redler A, Costamagna G, Cucchiara S. Second-generation colon capsule endoscopy vs. colonoscopy in pediatric ulcerative colitis: a pilot study. Endoscopy. 2014 Jun;46(6):485-92. doi: 10.1055/s-0034-1365413. Epub 2014 Apr 28. |
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