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El ensayo clínico NCT06970808 (Cold-SNAPS) para Adenoma Colorrectal, Lesiones colorrectales está aún no recluta. 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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Cold Snare Versus Cold Forceps Polypectomy for Small Lesions (Cold-SNAPS) 312 Aleatorizado Diseño cruzado
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 NCT06970808 (Cold-SNAPS) es un estudio intervencionista para Adenoma Colorrectal, Lesiones colorrectales. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de diciembre de 2025 hasta completar 312 participantes. Dirigido por Azienda USL Modena, se espera que finalice el 1 de diciembre de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 14 de mayo de 2025.
Resumen
The goal of this clinical trial is to compare the efficacy and the safety of a new device for cold forceps polypectomy (CFP)- a special jumbo forceps- to cold snare polypectomy (CSP) for small colorectal lesions, without adding peri- or post-procedural risks to the patient.
The main questions it aims to answer are:
- Does the cold forceps guarantee a complete endoscopic resection rate?
- How many adverse events cou...
Descripción detallada
The study is a Multicenter, Prospective, Randomized, Controlled Study. It is designed as a non-inferiority trial to assess whether the efficacy in polypectomy of the new jumbo cold forceps is non-inferior to that of the cold snare.
The investigators hypothesize a less number of adverse events with CFP, an increased lesion retrieval rate and a less duration of the polypectomy procedure.
All patients will be contacte...
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Cold SNAre Versus Cold forcePS Polypectomy for Small Colorectal Lesions (Cold-SNAPS): a Multicenter Randomized Trial
Condiciones médicas
Adenoma ColorrectalLesiones colorrectalesOtros ID del estudio
- Cold-SNAPS
- 04-2025
Número del NCT
Inicio del estudio (real)
2025-12
Última actualización
2025-05-14
Fecha de finalización (estimada)
2027-12
Inscripción (prevista)
312
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
Cold forceps polypectomy
Colonoscopy
Cold snare polypectomy
Colonoscopy
Cold snare polypectomy
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Comparador activoCold snare polypectomy group For CSP, a 10 mm cold snare will be used (cold snare, Boston Scientific Corporation®, Marlborough, Massachusetts and cold snare, Meditalia S.A.S.®, Palermo, Italy); for CFP, a dedicated forceps will be used (Leviathan® cold forceps, 10 mm opening; Meditalia S.A.S., Palermo, Italy) | Sampling from the resection margins After polypectomy, the base will be irrigated and assessed by the endoscopist, who may also use virtual or vital chromoendoscopy, if needed.
Any residual adenomatous tissue will be removed using the same technique. To confirm the completeness of each polypectomy, two biopsies will be taken from the resection margins for polyps ≤ 5 mm, and three biopsies for polyps 6-9 mm, using standard biopsy forces. |
ExperimentalCold forceps polypectomy group For CFP, Leviathan® will be used (Meditalia S.A.S., Palermo, Italy). The opening jaw reaches a 10 mm diameter, and the central section of each jaw has an enlarged diameter up to 3.6 mm compared to the oval axis, enhancing its capacity | Sampling from the resection margins After polypectomy, the base will be irrigated and assessed by the endoscopist, who may also use virtual or vital chromoendoscopy, if needed.
Any residual adenomatous tissue will be removed using the same technique. To confirm the completeness of each polypectomy, two biopsies will be taken from the resection margins for polyps ≤ 5 mm, and three biopsies for polyps 6-9 mm, using standard biopsy forces. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Incomplete resection rate | Compare the rate of incomplete endoscopic resection (IER) of CFP and CSP, defined as the presence of residual adenomatous tissue in the biopsy samples of the margins or after the visual assessment of the resection base. | Immediately after the procedure and immediately after the histological evaluation of the biopsy samples |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Adverse events | Intraprocedural bleeding (i.e., post-polypectomy "spurting" or "oozing" bleeding lasting more than one minute of observation, requiring hemostatic interventions) and delayed bleeding (within 30 days of the procedure, requiring a second endoscopic treatment and/or hospitalization); perforation (intraprocedural or delayed), defined as grade III (damage to the muscular layer with recognition of the "target sign") or grade IV/V (full-thickness perforation of the bowel wall with or without contamination, respectively) according to the Sydney Classification.
All patients will be contacted, 30 days post-polypectomy, by blinded medical staff assessing for possible complications (rectal bleeding, abdominal pain, hospitalization due to perforation/bleeding, etc.) | Up to 30 days after the procedure |
Lesion retrieval rate | Lesion retrieval rate, in relation to the resection site | During the polypectomy |
Polypectomy duration | Polypectomy duration evaluated in seconds: the time will be calculated from the exit of the device from endoscopic channel to the lesion retrieval. Cold forceps polypectomy is assumed to have a shorter procedural time, reducing the overall colonoscopy duration, improving patient compliance, and reducing the sedation required, with fewer risks related to sedation | During the polypectomy |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- Patients aged ≥ 18 years;
- Ability to provide informed consent;
- Presence of at least one colorectal polypoid/non-polypoid lesion < 10 mm
- Primary or secondary coagulopathy;
- Improper interruption of dual antiplatelet therapy and/or antiplatelet therapy with P2Y12 receptor antagonists (clopidogrel, prasugrel, ticagrelor) and/or anticoagulant therapy;
- Chronic inflammatory bowel diseases;
- Inpatients undergoing colonoscopy;
- Colonoscopy as part of regional colorectal cancer screening;
- Pregnancy or breastfeeding
Azienda USL ModenaParte responsable del estudio
Dr. Mauro Manno, Investigador principal, Gastroenterology and Endoscopy Unit director, Azienda USL Modena
Contactos centrales del estudio
Contacto: Noemi Gualandi, +39 059659500, [email protected]
1 Centros del estudio en 1 países
Modena
AUSL Modena, Carpi, Modena, 41012, Italy
Mauro Manno, Principal investigator, Contacto, +39 059659250, [email protected]