Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
3 de febrero de 2017 actualizado por: BBraun Medical SAS
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Dijon, Francia, 21000
- Centre Georges Francois Leclerc
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patient is at least 18 years old
- Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
- Patient having a colostomy for at least 1 month
- Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
- Patient having a stoma protusion smaller than or equal to 1.5 cm
- Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
- Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- Patient agreeing to test the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
- Patient covered by social security
Exclusion Criteria:
- Patient experiencing repeated leakages with the usual pouching system
- Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
- Patient already participating in another clinical study or who have previously participated in this investigation
- Pregnant or breast-feeding woman
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: AOS-C2000-B
A new 2-piece appliance composed with 2 parts : a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)
|
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Description of efficacy in term of type of bag deployment and leakage prevention
Periodo de tiempo: At least 1 time per day during 14±3 days
|
After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"
|
At least 1 time per day during 14±3 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peristomal skin evaluation with DET score scale
Periodo de tiempo: baseline and 5±3 days and 14±3 days
|
baseline and 5±3 days and 14±3 days
|
|
|
Investigational product bag deployment reason
Periodo de tiempo: At each bag change during 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
At each bag change during 14±3 days
|
|
Ease of bag deployment
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Ease of special bag handling
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Investigational product bag ease of use of gas release button
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Ease of control of gas release button
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
General impression about the investigational device before use
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Investigational device wearing comfort
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Investigational device flexibility
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Investigational device discretion
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Ease of base plate handling
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Investigational device adhesivity during wear time
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Investigational device filter performance with deployed bag
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Investigational device filter performance with undeployed bag
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Efficacy of Investigational device gas release button
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Noise during Investigational device wear time
Periodo de tiempo: 14±3 days
|
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device
Periodo de tiempo: 14±3 days
|
14±3 days
|
|
|
Overall security feeling questionnaire with the Investigational device
Periodo de tiempo: 14±3 days
|
14±3 days
|
|
|
Overall satisfaction questionnaire with the Investigational device
Periodo de tiempo: 14±3 days
|
14±3 days
|
|
|
Overall satisfaction questionnaire regarding bag deployment of the Investigational device
Periodo de tiempo: 14±3 days
|
14±3 days
|
|
|
Overall satisfaction questionnaire with cap cover of the Investigational device
Periodo de tiempo: 14±3 days
|
14±3 days
|
|
|
General impression about body image during use of the investigational product
Periodo de tiempo: 14±3 days
|
(4-points very satisfying to not at all satisfying)
|
14±3 days
|
|
Assessment questionnaire of willingness to use and the frequency of use in the future
Periodo de tiempo: 14±3 days
|
14±3 days
|
|
|
Assessment of the investigational device wear time
Periodo de tiempo: 14±3 days
|
14±3 days
|
|
|
Assessment questionnaire preference between the investigational device and usual appliance
Periodo de tiempo: 14±3 days
|
14±3 days
|
|
|
Assessment of use of accessories
Periodo de tiempo: At each bag change during 14±3 days
|
Choice between some accessories
|
At each bag change during 14±3 days
|
|
Assessment of the quality of life with Stoma-QoL questionnaire
Periodo de tiempo: At baseline, at 5±3 days and 14±3 days
|
At baseline, at 5±3 days and 14±3 days
|
|
|
Number of participants with Adverse Event as a measure of safety and tolerability
Periodo de tiempo: At baseline, at 5±3 days and 14±3 days
|
At baseline, at 5±3 days and 14±3 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mahaut LECONTE, MD, University Hospital of Paris - Cochin
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2015
Finalización primaria (Actual)
1 de octubre de 2016
Finalización del estudio (Actual)
1 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
4 de noviembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
10 de noviembre de 2015
Publicado por primera vez (Estimar)
11 de noviembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de febrero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
3 de febrero de 2017
Última verificación
1 de febrero de 2017
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- OPM-G-H-1401
- 2015-A00611-48 (Otro identificador: FRENCH HEALTH AUTORITY)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .