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Triton 1.5 Robotic System for Diagnostic Colonoscopy (CARE II)

18. maj 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Secondary Safety Endpoint - Mucosal Injury Score During Procedure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: During Procedure
Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma Unit of Measure: Percentage of participants
During Procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Marcin Romanczyk, MD, H-T Centrum Medyczne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

15. oktober 2026

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

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