Triton 1.5 Robotic System for Diagnostic Colonoscopy
Colonoscopy · Colorectal Cancer Screening
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 22 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 40 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This study is a prospective, single-arm, non-randomized, single-site study, focused on evaluating the safety and efficacy of the Triton 1.5 System in diagnostic and basic therapeutic colonoscopy.
Leer la descripción completa
This study is a prospective clinical investigation designed to evaluate the safety, and efficacy of the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2cm). Up to 40 subjects will undergo robotic colonoscopy using the Triton 1.5 System with three operating physicians.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. Age ≥ 22 years
2. Adults indicated for elective screening, surveillance or diagnostic colonoscopy
3. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
4. Subject is willing and able to comply with all protocol required preparation and follow- up visits
Exclusion Criteria:
1. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
2. Any active or magnetic implantable medical devices (e.g., pacemakers, defibrillators)
3. Previous failed colonoscopy (except for inadequate bowel preparation)
4. BMI \> 45 kg/m2
5. Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).
6. Surgically altered colonic anatomy
7. History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, hereditary nonpolyposis colorectal cancer (Lynch) syndrome, sclerosing encapsulating peritonitis, active diverticulitis in last 6 months or toxic megacolon
8. Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
9. Known bleeding tendency such as hemophilia or coagulation factor deficiencies
10. Subject receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin
11. Known colonic stricture
12. Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment
13. Known abdominal wall hernias
14. History of radiotherapy to the abdomen or pelvis
15. History of mesenteric ischemia
16. Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure
17. Contraindication to the proposed sedation / anesthesia
18. Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure
19. Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure
20. Participation in any concurrent clinical trial that may impact the results of this study
Intra-Operative Criteria:
1. Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score \< 2 in any segment.
2. Any intraoperative finding or condition that, in the Investigator's judgment, would make study participation unsafe or not in the subject's best interest (e.g., significant stricture, tight sigmoid colon precluding safe overtube passage).
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Single Arm
This study is a prospective, single-arm, non-randomized, single-site study, which is deigned to evaluate the safety and efficacy of the Triton 1.5 System for performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤2cm) during endoscopic procedures.
Device: Diagnostic Test: Diagnostic Colonoscopy
Diagnostic Test: Diagnostic Colonoscopy DEVICE
This study will serve to evaluate the safety and efficacy of the Triton 1.5 System for performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤2cm).
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
Plazo: 48 Hours
Absence of Major Adverse Events (MAEs) within 48 hours of the procedure. MAEs are defined as the following: (a) Device-related death within 48 hours, (b) Perforation within 48 hours, (c) Intraprocedural bleeding preventing completion of the procedure, (d) Delayed bleeding within 48 hours accompanied by predefined symptoms and confirmed by a hemoglobin drop of \>2 g, as applicable, leading to admission to hospital, prolongation of existing hospital stay, another procedure (requiring sedation/anesthesia).
Unit of Measure: Number of participants with at least one Major Adverse Event
Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure
Plazo: During Procedure
Completion of colonoscopy defined by both: (a) Successful cecal intubation with visualization of the appendiceal orifice, (b) Successful withdrawal with clinically acceptable diagnostic inspection and therapeutic access.
Medidas secundarias
Secondary Safety Endpoint - Mucosal Injury Score During Procedure
Plazo: During Procedure
Mucosal Injury graded using a visual assessment of the colonic wall during withdrawal of the procedure using the following scale: (1) Erythema / Bruising, (2) Mucosal break \< 5 mm, (3) Mucosal break \> 5 mm, (4) Muscle injury (non-full thickness), (5) Full-thickness injury.
Unit of Measure: Score (1-5), higher scores indicate more severe injury
Secondary Safety Endpoint - Delayed Bleeding Within 14 Days
Plazo: 14 days post-procedure
Delayed bleeding within 14 days, defined as: bleeding within 48 hours accompanied by pre-defined symptoms and confirmed by a hemoglobin drop \> 2 g, leading to admission to hospital, prolongation of existing hospital stay, another procedure (requiring sedation/anesthesia).
Secondary Safety Endpoint - Delayed Perforations Within 14 Days
Plazo: 14 days post-procedure
Delayed perforations within 14 days, defined as: perforations occurring within 14 days post-procedure.
Secondary Efficacy Endpoint - Time to Cecum During Procedure
Plazo: During Procedure
Interval from nested-system insertion at the anal verge to first visualization of the appendiceal orifice. Pauses for ancillary or therapeutic tasks (e.g., biopsy, polypectomy ≤ 2 cm, repositioning, prolonged washing) are recorded and subtracted to isolate insertion performance. For polypectomy pauses, time is measured from first polyp visualization to confirmation of retrieval in the specimen trap.
Unit of Measure: Minutes or seconds
Secondary Efficacy Endpoint - Need for Repositioning During Procedure
Plazo: During Procedure
Number of times a participant was repositioned during the procedure. Unit of Measure: Number of repositioning events
Secondary Efficacy Endpoint - Polypectomy Success During Procedure
Plazo: During Procedure
Clinically acceptable polypectomy performed with cold forceps, cold snare, or hot snare leaving no visible residual polyp. Polyps \> 2 cm or lesions too complex for diagnostic colonoscopy are excluded and deferred for later advanced therapy.
Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure
Plazo: Immediately after Procedure
Physician's subjective workload assessment using the NASA Task Load Index (NASA-TLX), a validated tool consisting of six subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is scored from 0 to 100 in increments of 5. Higher scores indicate greater perceived workload. Unit of Measure: Composite score (0-600)
Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure
Plazo: During Procedure
Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma Unit of Measure: Percentage of participants
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
HT Centrum MedyczneTychy, Silesian Voivodeship, PolandEstado desconocido
Equipo y fechas
- Patrocinador principal
- Neptune Medical
- Inicio del estudio
- 24 ago 2026 Real
- Finalización primaria
- 9 sept 2026 Real
- Finalización del estudio
- 18 sept 2026 Real
- Primera publicación
- 26 may 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026