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Triton 1.5 Robotic System for Diagnostic Colonoscopy (CARE II)

14 septembre 2026 mis à jour par: Neptune Medical

Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Silesian Voivodeship
      • Tychy, Silesian Voivodeship, Pologne, 43-100
        • HT Centrum Medyczne

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: 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.
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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
Délai: 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

48 Hours
Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure
Délai: 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.
During Procedure

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Secondary Safety Endpoint - Mucosal Injury Score During Procedure
Délai: 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

During Procedure
Secondary Safety Endpoint - Delayed Bleeding Within 14 Days
Délai: 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).
14 days post-procedure
Secondary Safety Endpoint - Delayed Perforations Within 14 Days
Délai: 14 days post-procedure
Delayed perforations within 14 days, defined as: perforations occurring within 14 days post-procedure.
14 days post-procedure
Secondary Efficacy Endpoint - Time to Cecum During Procedure
Délai: 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

During Procedure
Secondary Efficacy Endpoint - Need for Repositioning During Procedure
Délai: During Procedure
Number of times a participant was repositioned during the procedure. Unit of Measure: Number of repositioning events
During Procedure
Secondary Efficacy Endpoint - Polypectomy Success During Procedure
Délai: 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.
During Procedure
Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure
Délai: 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)
Immediately after Procedure
Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure
Délai: During Procedure
Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma Unit of Measure: Percentage of participants
During Procedure

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Marcin Romanczyk, MD, H-T Centrum Medyczne

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 août 2026

Achèvement primaire (Réel)

9 septembre 2026

Achèvement de l'étude (Estimé)

23 septembre 2026

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

26 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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