Evidence generation plan for robot-assisted surgery for soft tissue procedures
1 Purpose of this document
NICE's early value assessment of robot-assisted surgery for soft tissue procedures recommends that Da Vinci SP, Da Vinci X and Xi, Hugo robotic-assisted surgical system, Senhance Surgical System and Versius Surgical System can be used in the NHS during the evidence generation period.
This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technology again in the future. It is not a study protocol but suggests an approach to generating the information needed to address the evidence gaps. For assessing comparative treatment effects, well-conducted randomised controlled trials are the preferred source of evidence if these are able to address the research gap.
The companies are responsible for ensuring that data collection and analysis takes place. Support for evidence generation may be available through schemes such as the National Institute for Health and Care Research (NIHR)-funded HealthTech Research Centres.
Guidance on commissioning and procurement of the technologies will be provided by NHS England.
NICE will revise or withdraw the guidance if the companies do not meet the conditions in section 4 on monitoring.
After the end of the evidence generation period (3 years), the companies should submit the evidence to NICE in a format that can be used for decision making. NICE will review all the evidence and assess whether the technologies can be routinely adopted in the NHS.
Once the evidence generation period has concluded, further data about the effectiveness of robot-assisted surgery systems should continue to be collected to support planning and decision making. This could be accomplished through suitable national data collections, either by amending existing registries or potentially creating a new one.
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