Pediatrics, Colon Capsule Endoscopy Clinical Trial
Official title:
EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS
| Verified date | November 2012 |
| Source | Azienda Policlinico Umberto I |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Observational |
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
1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with
standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | February 2013 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 18 Years |
| Eligibility |
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: - diagnosis of UC made at least 3 months before the enrolment; - subject was referred for standard colonoscopy and endoscopic follow-up in Ulcerative colitis - signed informed consent. Exclusion criteria The presence of any of the following will exclude a subject from study enrollment: - Subject has dysphagia - Subject has renal insufficiency - Subject is known or suspected structuring CD. - Subject has a cardiac pacemaker or other implanted electro medical devices. - Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. - Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Sapienza - University of Rome | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Policlinico Umberto I |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Secondary | 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) | Yes |