- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07606963
Triton 1.5 Robotic System for Diagnostic Colonoscopy (CARE II)
Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hayley Holm
- Telefonní číslo: (650) 922-5512
- E-mail: hayley.holm@neptunemedical.com
Studijní záloha kontaktů
- Jméno: Min-Sun Son
- Telefonní číslo: (650) 714-1803
- E-mail: minsun@neptunemedical.com
Studijní místa
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Silesian Voivodeship
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Tychy, Silesian Voivodeship, Polsko, 43-100
- HT Centrum Medyczne
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Dílčí vyšetřovatel:
- Marcin Romanczyk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age ≥ 22 years
- Adults indicated for elective screening, surveillance or diagnostic colonoscopy
- Subject is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
- Subject is willing and able to comply with all protocol required preparation and follow- up visits
Exclusion Criteria:
- Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
- Any active or magnetic implantable medical devices (e.g., pacemakers, defibrillators)
- Previous failed colonoscopy (except for inadequate bowel preparation)
- BMI > 45 kg/m2
- Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).
- Surgically altered colonic anatomy
- 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
- Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
- Known bleeding tendency such as hemophilia or coagulation factor deficiencies
- Subject receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin
- Known colonic stricture
- Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment
- Known abdominal wall hernias
- History of radiotherapy to the abdomen or pelvis
- History of mesenteric ischemia
- Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure
- Contraindication to the proposed sedation / anesthesia
- Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure
- Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure
- Participation in any concurrent clinical trial that may impact the results of this study
Intra-Operative Criteria:
- Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score < 2 in any segment.
- 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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Jiný: 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.
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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).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
Časové okno: 48 Hours
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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
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Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure
Časové okno: During Procedure
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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.
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During Procedure
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Secondary Safety Endpoint - Mucosal Injury Score During Procedure
Časové okno: During Procedure
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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
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Secondary Safety Endpoint - Delayed Bleeding Within 14 Days
Časové okno: 14 days post-procedure
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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).
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14 days post-procedure
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Secondary Safety Endpoint - Delayed Perforations Within 14 Days
Časové okno: 14 days post-procedure
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Delayed perforations within 14 days, defined as: perforations occurring within 14 days post-procedure.
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14 days post-procedure
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Secondary Efficacy Endpoint - Time to Cecum During Procedure
Časové okno: During Procedure
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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
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Secondary Efficacy Endpoint - Need for Repositioning During Procedure
Časové okno: During Procedure
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Number of times a participant was repositioned during the procedure.
Unit of Measure: Number of repositioning events
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During Procedure
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Secondary Efficacy Endpoint - Polypectomy Success During Procedure
Časové okno: During Procedure
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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.
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During Procedure
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Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure
Časové okno: Immediately after Procedure
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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)
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Immediately after Procedure
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Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure
Časové okno: During Procedure
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Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma Unit of Measure: Percentage of participants
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During Procedure
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Marcin Romanczyk, MD, H-T Centrum Medyczne
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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