临床试验/NCT07761299

NCT07761299尚未招募不适用

Robotic-Assisted Surgery With Versius in the NHS: Retrospective Comparative Performance Study Across Multiple Soft-Tissue Specialties

CMR Surgical Ltd0 个研究点目标入组 1,200 人开始时间: 2026年8月1日最近更新: 2026年8月12日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: CMR Surgical Ltd
入组人数: 1,200
主要终点: Procedure related complication rates

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To generate robust, real-world comparative evidence on the short and long-term clinical outcomes following surgical intervention with Versius Robot-Assisted Surgery versus surgical standard of care across predefined soft-tissue index procedures in routine NHS practice.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patients undergoing one of the index procedures with Versius, laparoscopically or with open surgery.
•Patients who provide written consent (16 years or older) or for whom an appropriate legal representative who provides written informed consent (<16 years old).

排除标准

•Patients participating in an interventional clinical study that might impact the defined endpoints.
•Patients undergoing concomitant surgery.
•Patients or appropriate legal representatives unwilling to provide written consent.
•Patients with BMI at or above 40 kg/m2.

研究组 & 干预措施

Versius Robotic-Assisted Surgery

Patients undergoing soft-tissue surgical procedures using the Versius Surgical System

Non-Versius Surgical Cohort

Patients undergoing comparable soft-tissue surgical procedures using non-Versius surgical approaches (conventional laparoscopic and open surgery).

结局指标

主要结局

Procedure related complication rates

时间窗: Within 30 days and 12 months after surgery

Rate of total procedure related complications within 30 days and up to 12 months following surgery

次要结局

Length of hospital stay(Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days)
Conversion rate(Up to completion of surgery)
Operative time(Up to completion of surgery)
Revision surgery rate(Within 12 months following surgery)
Rate of pre-defined index procedure specific complications(Within 30 days and 12 months after surgery)

研究者

发起方

CMR Surgical Ltd

申办方类型

Industry

责任方

Sponsor

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