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Triton 1.5 Robotic System for Diagnostic Colonoscopy (CARE II)

18. Mai 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • Silesian Voivodeship
      • Tychy, Silesian Voivodeship, Polen, 43-100
        • HT Centrum Medyczne
        • Unterermittler:
          • Marcin Romanczyk

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Secondary Safety Endpoint - Mucosal Injury Score During Procedure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During Procedure
Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma Unit of Measure: Percentage of participants
During Procedure

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Hauptermittler: Marcin Romanczyk, MD, H-T Centrum Medyczne

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

30. September 2026

Studienabschluss (Geschätzt)

15. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

11. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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