Evaluation Of The Pillcam™ Colon Capsule Endoscopy (Pcce-2) In Pediatric Ulcerative Colitis
EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS
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
- To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
- To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Rome, Italia, 00161
- Sapienza - University of Rome
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
The Given® 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 Given® 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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
Lasso di tempo: Day 3 (after colonoscopy and CCE-2)
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Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy in pediatric Ulcerative Colitis.
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Day 3 (after colonoscopy and CCE-2)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.
Lasso di tempo: Day 3 (after colonoscopy and CCE-2)
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Number, type and severity of adverse events with both PCCE and standard colonoscopy
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Day 3 (after colonoscopy and CCE-2)
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Collaboratori e investigatori
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Primo Inserito (Stima)
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Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PCCE-2 GIVEN
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