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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?

  • Question on Document

    Is there any ongoing study in addition to the REINFORCE trial and the MASTERY cohort study that we may have missed and could be used to address any evidence gaps?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Evidence generation plan

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1 Purpose of this document

NICE's 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 while more evidence is generated.

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 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 form 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.

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