Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions

Официальное название

Colonoscopy With a Robotic Endoscope, The CARE I Study

Обзор

This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.

Вмешательства

• Диагностический тест Diagnostic Colonoscopy
  Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.

Первичные конечные точки

• Safety Endpoint - Incidence of Major Adverse Events Within 48 Hours [Срок оценки: 48 hours]
• Efficacy Endpoint - Successful Completion of Colonoscopy [Срок оценки: During procedure]

Вторичные конечные точки (8)

• Time to Cecum [Срок оценки: During procedure]
• Need for Repositioning [Срок оценки: During procedure]
• Polypectomy Success [Срок оценки: During procedure]
• NASA Task Load Index (NASA-TLX) [Срок оценки: Post-procedure]
• Mucosal Injury Score [Срок оценки: During procedure]
• Delayed Bleeding (14 Days) [Срок оценки: 14 days]
• Delayed Perforation (14 Days) [Срок оценки: 14 days]
• Adenoma Detection Rate (ADR) [Срок оценки: During procedure]

Критерии участия

Критерии включения

• 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 Clinical Investigation Plan specific procedures
• Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -

Критерии исключения

Initial Screening / Pre-Operative:

• Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
• Any active 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
• Patient 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 Exclusion Criteria:

• Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) < 2 in any section
• Failed conventional colonoscopy or polypectomy/biopsy performed during the conventional colonoscopy procedure in Phase A
• Any presenting condition discovered intraoperatively that in the opinion of the investigator would make participating in this study not in the participant's/patient's best interest. For example, presence of a stricture or tight sigmoid that would make passing an overtube risky for the patient
• Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06935734 · CP-000001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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