Evaluation Of The Pillcam™ Colon Capsule Endoscopy (Pcce-2) In Pediatric Ulcerative Colitis

Azienda Policlinico Umberto I

Status: Completed

Conditions: Pediatrics, Colon Capsule Endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT01740349

PCCE-2 GIVEN

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

30 participants in 1 patient group

30 children with UC

Description:

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.