Versius Paediatrics Study

Официальное название

Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics

Обзор

This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device) in Urological Procedures in Paediatric population. In alignment with IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework, this study will consist of 3 main phases to ensure proper procedure development while ensuring patients safety. Feasibility and safety will be assessed on an ongoing basis, and specifically after completion of the first 3 procedures, at a single site (Southampton/Lead), each conducted one week apart to allow the identification of unanticipated risks/adverse events. Once deemed safe, based on the results of the 3 cases enrolled in Phase I, 7 further cases would be completed, at the same site. Once the procedure is deemed safe according to safety data collected, the recruitment will proceed to full trial patient accrual, 140 additional cases from the 3 participating study sites.The study patient population is children and adolescents under the age of 18, which will be provided clinical care and follow-ups per standard of care and hospital's policy.

Вмешательства

• Устройство Versius Surgical System
  Urological minimal access surgery performed with Versius Surgical System

Первичные конечные точки

• Adverse Event rate [Срок оценки: Up to 3 months post operation]

Вторичные конечные точки (12)

• Procedure completion [Срок оценки: Day of operation]
• Serious Adverse Event Rate [Срок оценки: Up to 3 months post-operation]
• Ultrasound grading [Срок оценки: 3 months post stent removal]
• MAG3 Renogram [Срок оценки: 3 months post stent removal]
• Operative time [Срок оценки: Day of operation]
• Blood loss [Срок оценки: Day of operation]
• Post operative analgesic treatment [Срок оценки: Immediately after surgery]
• Length of stay [Срок оценки: Up to 3 months post operation, average 1 day]
• Reoperation [Срок оценки: 24 hours post operation]
• Unplanned readmission [Срок оценки: Up to 3 months post operation]
• Device deficiencies and user errors [Срок оценки: Day of operation]
• Ultrasound grading [Срок оценки: 12 months post operation]

Критерии участия

Критерии включения

• Patients, male or female, (<18 years old) for whom an appropriate legal representative provides written consent for participation
• Patient and disease factors deemed suitable for minimal access urological procedure
• Multidisciplinary team (MDT) decision to treat with surgery
• Patients under the care of the paediatric urology team in one of the participating centres

Критерии исключения

• Patients ≥ 18 years old
• Appropriate legal representative unwilling to provide written consent
• Medical contraindication for general anaesthesia
• Medical contraindication for laparoscopic procedure
• Active pregnancy (in post-pubertal female patients)
• Morbid obesity (BMI ≥ 40 kg/m2)
• Patient participation in an interventional clinical study, that could impact primary objectives results
• Prior pelvic /abdominal radiotherapy treatment
• Subjects with other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 3 центра

• Department of Paediatric Urology, Evelina London Children's Hospital — London
• Department of Paediatric Urology Royal Manchester Children's Hospital — Manchester
• Department of Paediatric Urology Southampton Children's Hospital — Southampton

Идентификаторы

NCT: NCT06539442 · CA-00533

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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