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The Clinical Application of MCCES in Examination of Human Colon

26 de agosto de 2015 actualizado por: Nanfang Hospital of Southern Medical University

The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon

This study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the Western world. The screening tests include flexible sigmoidoscopy, optical colonoscopy (OC), double-contrast barium enema , or CT colonography . Such screening can reduce CRC incidence and mortality but its effectiveness depends on its quality, ease of use, and patient adherence .Colon capsule endoscopy(CCE) is being actively evaluated as an emerging complementary or alternative procedure for evaluation of the colon. magnetic -controlled capsule endoscopy system is a new ingestible colon capsule robot provided by Chongqing Jinshan Science & Technology. While Screening the colon, the capsule is drove by magnetic-manipulator outside the body, which means it can move from the cecum to anus step by step under the control of the doctor. However, there's little data report on this colon capsule robot system in clinical application. The investigators plan to conduct this prospective study to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

80

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

  • Porcelana
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510515
        • Reclutamiento
        • Nanfang Hospital of Southern Medical University
        • Contacto:
          • huiling Zheng, master
          • Número de teléfono: +86 15013113215
          • Correo electrónico: bywxling@163.com

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 a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or
  • Patients who volunteer to the colonoscopy screening.

Exclusion Criteria:

  • Dysphagia or swallowing disorder,
  • Congestive heart failure,
  • Renal insufficiency,
  • Prior major abdominal surgery of the gastrointestinal tract,
  • Known or suspected bowel obstruction,
  • Presence of a cardiac pacemaker or other implanted electromedical devices,
  • Allergy or contraindication to the medications used in the study.

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: Diagnóstico
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: MCCES
Magnetic -controlled capsule endoscopy system (MCCES) is a robot system that the capsule would be swallowed to observe the mucosa of the human alimentary canal especially the colon under the control of the magnetic-manipulator.
Procedimiento: magnetic-controlled capsule endoscopy system
  1. A magnetic-controlled capsule endoscopy(MCCE) included camera,magnet,batter and high polymer material shell.
  2. The MCCE would be turned to sleeping mode capturing picture at a rate of 0.5 frame per second after being swallowed.
  3. While reaching cecum, the MCCE would be turned to a working mode capturing picture at a rate of 2 frame per second.
  4. The MCCE would be controlled by the Magnetic-manipulator out of body to finish the motion of e rotation, somersault, Bird's-eye view, worm's eye view from cecum to anus.
Comparador activo: Colonoscopy
Colonoscopy has now been in use for many years to visualize and diagnose abnormalities of the colon and it is the gold standard for detecting colorectal lesions.In this study,the additional utility of the colonoscopy is to monitor the movement of the Magnetic -controlled capsule endoscopy.
Procedimiento: Colonoscopy
  1. Bowel preparation should be well done before the examination.
  2. A tube with illumination and camera system would insert into colon from anus.
  3. From the pictures captured by the camera ,the doctor would see the mucous of the colon.
Otros nombres:
  • colonoscope

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maneuverability
Periodo de tiempo: From the MCCES examination began until the capsule excreted, an expected average of 24h
The Maneuverability was defined as the rotation, somersault, Bird's-eye view, worm's eye view of the capsule, and completing any motion would gain 1 point, eventually ,4 point was good,2-3 point moderate,0-1point poor.
From the MCCES examination began until the capsule excreted, an expected average of 24h

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Migration length of anus direction
Periodo de tiempo: From the MCCES examination began until the capsule excreted, an expected average of 24h
Migration length of anus direction was defined as how long was the distance the capsule controlled by the Magnetic-manipulator moved from cecum to anus in 25 minutes.
From the MCCES examination began until the capsule excreted, an expected average of 24h
The movement of mouth direction
Periodo de tiempo: From the MCCES examination began until the capsule excreted, an expected average of 24h
The movement of mouth direction was defined as if the capsule controlled by the Magnetic-manipulator could move from any point of the colon towards mouth direction.
From the MCCES examination began until the capsule excreted, an expected average of 24h
Nidus of colon
Periodo de tiempo: During the procedure
From date of the examination until the date of pathological diagnosis, an expected average of 7 days
During the procedure
The level of cleanliness
Periodo de tiempo: From the MCCES examination began until the capsule excreted, an expected average of 24h
The cleanliness of the colon was graded as excellent (No more than small bits of adherent feces),good(Small amount of feces or dark fluid,but not enough to interfere with the examination ),fair(Enough feces or dark fluid present to preclude a completely reliable examination),poor(large amount of fecal residue).
From the MCCES examination began until the capsule excreted, an expected average of 24h
Procedure related complication
Periodo de tiempo: From the day of the examination until the follow up ended ,access up to 7 days.
Perforation, capsule retention, abdominal pain and so .etc.
From the day of the examination until the follow up ended ,access up to 7 days.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Nanfang Hospital of Southern Medical University

Investigadores

  • Investigador principal: Bo Jiang, doctor, Nanfang Hospital of Southern Medical University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

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 agosto de 2015

Finalización primaria (Anticipado)

1 de septiembre de 2015

Finalización del estudio (Anticipado)

1 de septiembre de 2015

Fechas de registro del estudio

Enviado por primera vez

24 de agosto de 2015

Primero enviado que cumplió con los criterios de control de calidad

26 de agosto de 2015

Publicado por primera vez (Estimar)

31 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

31 de agosto de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

26 de agosto de 2015

Última verificación

1 de agosto de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NFEK-2015-046

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. .

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