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El ensayo clínico NCT07005453 (ASSEMBLE) para Colorectal Polyps 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. | ||
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Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size (ASSEMBLE) 241 Aleatorizado
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El ensayo clínico NCT07005453 (ASSEMBLE) es un estudio intervencionista para Colorectal Polyps. Su estado actual es: reclutando. El estudio se inició el 23 de septiembre de 2025, con el objetivo de reclutar a 241 participantes. Dirigido por Erasmus Medical Center, se espera que finalice el 1 de abril de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 13 de enero de 2026.
Resumen
A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population.
Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.
Descripción detallada
Objective: This study aims to assess the diagnostic performance of SCALE-EYE in a screening and surveillance colonoscopy population. Also, sustainability of SCALE-EYE in terms of the reduction in colonoscopies, associated waste and carbon footprint is evaluated.
Study design: A multicenter, randomized, parallel group, endoscopist blinded study.
Study population: The unit of analysis is the colorectal polyp rather t...
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Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
Condiciones médicas
Colorectal PolypsOtros ID del estudio
- ASSEMBLE
- MEC-2024-0789
Número del NCT
Inicio del estudio (real)
2025-09-23
Última actualización
2026-01-13
Fecha de finalización (estimada)
2026-04-01
Inscripción (prevista)
241
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
virtual scale endoscopy
biopsy forceps
optical assessment
colorectal cancer
biopsy forceps
optical assessment
colorectal cancer
Objetivo principal
Diagnóstico
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
OtrosSCALE-EYE measurement than biopsy-forceps assisted measurement When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by SCALE-EYE measurement and afterwards by biopsy-forceps assisted measurement. | SCALE-EYE (1) Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement. |
OtrosBiopsy-forceps assisted measurement than SCALE-EYE measurement When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by biopsy-forceps assisted measurement and afterwards by SCALE-EYE measurement. | SCALE-EYE (2) Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
SCALE-EYE diagnostic performance versus biopsy-forceps | The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard. | Immediately after the screening and/or surveillance colonoscopy |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
SCALE-EYE diagnostic performance versus optical assessment | The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment for polyp size measurement. This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to optical assessment. | Immediately after the screening and/or surveillance colonoscopy |
Sustainability | The sustainability aspect of SCALE-EYE will be assessed by exploring whether the number of colonoscopies, the colonoscopy-associated waste and carbon footprint will be reduced by correct size measurement. | After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy) |
Learning curve | The learning curve will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty. | Immediately after the screening and/or surveillance colonoscopy |
Surveillance interval agreement | The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard (biopsy-forceps assisted measurement) will be compared. | After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy) |
(Serious) adverse events | Serious adverse events (SAEs) and adverse events (AEs) will be summarized by proportions. | Up to 30 days post-colonoscopy |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
55 Years
Criterios de sexo
Todos
- Participants aged 55-80
- Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy
- Polyps of all forms ≤25 mm as assessed by the endoscopist
- No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present
- Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) <2 per segment)
- Intraprocedural complications, not caused by the study device
- Known or suspected inflammatory bowel disease (IBD)
- Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis)
- Ileoanal pouch and anastomosis
- History of radiation or chemotherapy for colorectal lesions
- Scheduled for therapeutic procedure (for example intervention to stop a lower gastro-intestinal bleeding, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD))
- Pregnancy
- No Informed consent (IC) possible
Erasmus Medical CenterParte responsable del estudio
Peter Siersema, Investigador principal, Prof. Dr. P.D. Siersema, Erasmus Medical Center
No hay datos de contacto.
3 Centros del estudio en 1 países
North Brabant
Catharina Ziekenhuis, Eindhoven, North Brabant, 5623 EJ, Netherlands
Ramon-Michel Schreuder, Dr., Contacto, +31 40 2399750, [email protected]
Reclutando
South Holland
LUMC, Leiden, South Holland, 2333 ZG, Netherlands
Jurjen Boonstra, Dr., Contacto, +31 71 5263575, [email protected]
Reclutando
Erasmus MC, Rotterdam, South Holland, 3015 GD, Netherlands
Demi Gerritsen, MSc, Contacto, +31 650033985, [email protected]
Reclutando