NCT07761299Not yet recruitingNot Applicable
Robotic-Assisted Surgery With Versius in the NHS: Retrospective Comparative Performance Study Across Multiple Soft-Tissue Specialties
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- CMR Surgical Ltd
- Enrollment
- 1,200
- Primary Endpoint
- Procedure related complication rates
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
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).
Outcomes
Primary Outcomes
Procedure related complication rates
Time Frame: Within 30 days and 12 months after surgery
Rate of total procedure related complications within 30 days and up to 12 months following surgery
Secondary Outcomes
- 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)
Investigators
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