- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07661914
AI_Colonoscopy_for_Fellows
Efficacy of Artificial Intelligence Assisted Colonoscopy in Improving Adenoma Detection Rates for Gastroenterology Fellows
The goal of this study is to look at how good artificial intelligence (AI) assisted colonoscopy is compared to conventional colonoscopy in detecting polyps when used by gastroenterology fellows. The main question the study aims to answer are:
Does AI assisted colonoscopy improve adenoma detection rate for gastroenterology fellows in different levels of training? Does AI assisted colonoscopy improve other quality indicators such as sessile serrated lesion detection rate withdrawal time? This research will compare these quality measures for gastroenterology fellows in their first, second, and third year of training. The gastroenterology fellows performing colonoscopies will be randomized to either AI assisted colonoscopy or conventional colonoscopy for each case. The nurse in the room will then turn on the AI device if needed and the rest of the colonoscopy will be completed as normal. The procedure notes will indicated whether AI device was used or not during the procedure.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed study is a randomized controlled trial to evaluate the efficacy of AI assisted colonoscopies in improving colonoscopy quality indices for gastroenterology fellows.
The subjects for this study will be the gastroenterology fellows in their first, second or third year of training. Each fellow during their VA endoscopy rotation will be randomized to perform colonoscopies using AI or following conventional methods. If randomized to AI, the endoscopy technician in the procedural room will be responsible for turning on the GI Genius software (Medtronic AI device) during the procedure. The fellow will identify whether AI was used in the procedural note documented under Provation MD software. Otherwise, all colonoscopies will be performed in the standard fashion under moderate sedation or monitored anesthesia care. Procedures will not be affected by study participation. All procedures will be performed at the Oklahoma City VA Medical Center during normal procedural times. Information such as indication for the procedure and quality indices mentioned above (such as ADR, SSLDR, withdrawal time) will be obtained from chart review and calculated using data from Provation MD retrospectively, at a later time. Other information such as patient's medical history and family history as it relates to the colonoscopy procedure will also be collected retrospectively from CPRS chart records. This will be used to exclude patients undergoing colonoscopy secondary to genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) from this study. No identifiable patient information will be saved in any format. In addition, data such as polyp size, location of polyp and histological information will be collected from CPRS charts.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma City VA Health Care System
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- All adult gastroenterology fellows at the University of Oklahoma, except for the fellow conducting research will be included in the study.
Exclusion Criteria:
- All patients undergoing colonoscopy for genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) will be excluded from this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: AI assisted colonoscopy
GI fellows in this arm will complete colonoscopies with the assistance of AI device GI Genius.
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The gastroenterology fellows assigned to AI assisted colonoscopy will use the GI genius device while performing colonoscopies.
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Comparador activo: Conventional colonoscopy
GI fellows in this arm will complete colonoscopy in a conventional manner
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The gastroenterology fellows assigned to conventional colonoscopy will be performing colonoscopies without the use of AI device.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adenoma detection rate
Periodo de tiempo: over 18 months
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We hypothesize that an AI assisted colonoscopy done by a gastroenterology fellow will have a higher ADR as compared to conventional colonoscopy done by the same fellow and these results will be more significant among junior fellows compared to senior fellows.
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over 18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sessile serrated lesion detection rate
Periodo de tiempo: Over 18 months
|
We hypothesize that an AI assisted colonoscopy done by a gastroenterology fellow will have a higher sessile serrated lesion detection rate as compared to conventional colonoscopy done by the same fellow and these results will be more significant among junior fellows compared to senior fellow.
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Over 18 months
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|
Withdrawal time
Periodo de tiempo: Over 18 months
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Total withdrawal time will likely be longer in the AI assisted colonoscopy group compared to conventional colonoscopy group.
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Over 18 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mohammad Madhoun, University of Oklahoma
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 18531
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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