- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01740349
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Rome, Italia, 00161
- Sapienza - University of Rome
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PCCE-2 GIVEN
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