Back to resultsSECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
Primary Purpose
Pediatric, Colon Capsule Endoscopy
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Second generation of colon capsule endoscopy (GIVEN IMAGING)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pediatric
Eligibility Criteria
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 Crohn's Disease made at least 3 months before the enrolment;
- subject was referred for endoscopic and imaging follow-up in Crohn's Disease
- 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 structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
- 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 magnetic resonance enterography findings and clinical judgment of the investigator.
Sites / Locations
- Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CCE-2
Arm Description
Second generation of Colon capsule endoscopy in pediatric Crohn's disease
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02199626
First Posted
July 2, 2014
Last Updated
July 23, 2014
Sponsor
Azienda Policlinico Umberto I
1. Study Identification
Unique Protocol Identification Number
NCT02199626
Brief Title
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
Official Title
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Policlinico Umberto I
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the evaluation of pediatric Crohn's disease.
To evaluate the safety of CCE-2 in pediatric CD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric, Colon Capsule Endoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCE-2
Arm Type
Experimental
Arm Description
Second generation of Colon capsule endoscopy in pediatric Crohn's disease
Intervention Type
Device
Intervention Name(s)
Second generation of colon capsule endoscopy (GIVEN IMAGING)
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
3 days
Secondary Outcome Measure Information:
Title
To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease.
Description
Number, type and severity of adverse events with second generation of Crohn's disease.
Time Frame
two days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Crohn's Disease made at least 3 months before the enrolment;
subject was referred for endoscopic and imaging follow-up in Crohn's Disease
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 structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
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 magnetic resonance enterography findings and clinical judgment of the investigator.
Facility Information:
Facility Name
Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome
City
Rome
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
26363334
Citation
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.
Results Reference
derived
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SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
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