IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT05988645 para Cáncer colorrectal, Pólipo colorrectal, Adenoma Colorrectal, Pólipo adenomatoso colorrectal, Adenocarcinoma Colorrectal, Neoplasmas colorrectales está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un estudio coincide con los criterios de filtro
Vista de tarjeta
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II) 50
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05988645 es un estudio intervencionista para Cáncer colorrectal, Pólipo colorrectal, Adenoma Colorrectal, Pólipo adenomatoso colorrectal, Adenocarcinoma Colorrectal, Neoplasmas colorrectales. Su estado actual es: reclutando. El estudio se inició el 1 de agosto de 2023, con el objetivo de reclutar a 50 participantes. Dirigido por MiWEndo Solutions S.L., se espera que finalice el 29 de diciembre de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 29 de septiembre de 2025.
Resumen
The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an ...Mostrar más
Descripción detallada
This study is designed as a single-center prospective, non-comparative study in 50 patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis).
In this study the principal aims are to assess the performance and safety of the device for the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims...
Mostrar másTítulo oficial
Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
Condiciones médicas
Cáncer colorrectalPólipo colorrectalAdenoma ColorrectalPólipo adenomatoso colorrectalAdenocarcinoma ColorrectalNeoplasmas colorrectalesOtros ID del estudio
- MW II-CIP
Número del NCT
Inicio del estudio (real)
2023-08-01
Última actualización
2025-09-29
Fecha de finalización (estimada)
2025-12-29
Inscripción (prevista)
50
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
microwave imaging
colonoscopy
early diagnosis
colorectal cancer screening
colonoscopy
early diagnosis
colorectal cancer screening
Objetivo principal
Diagnóstico
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalMiWEndo + colonoscope All patients will be explored with MiWEndo as an accessory to colonoscopy | MiWEndo System All colonoscopies will be performed with high-definition technology. The MiWEndo System will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System. The MiWEndo Analyzer will be managed by the assistant.
At the beginning of the extubatio...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of polyps | With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients. | During the procedure. |
Number of adverse events. | Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54). | During the procedure and up to 2 weeks after. |
Number of mural injuries. | Mural injuries related with the use of the MiWEndo. | During the procedure and up to 2 weeks after. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number and size (adenomas and polyps). | The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy. | During procedure. |
True positives (TP), False positives (FP), False negatives (FN). | The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN). | During procedure. |
Patients' comfort. | Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort). | Immediately after the procedure and 2 weeks after. |
Perception of difficulty. | Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little). | Immediately after the procedure. |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Patients with a previously detected polyp in the rectum referred for resection.
These criteria will ensure the probability of finding polyps during the explorations.
All the patients will give written informed consent.
- Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
- ASA-IV patients.
- Urgent colonoscopy.
MiWEndo Solutions S.L.No hay datos de contacto.
1 Centros del estudio en 1 países
Hospital Clinic, Barcelona, Spain
Glòria Fernández, Contacto, 0034626710677, [email protected]
Reclutando