The multicentre prospective clinical trial is sponsored and managed by CMR Surgical (CMR), the Cambridge-based manufacturer of surgical robotic system, Versius, and is evaluating the safety and efficacy of Versius for use in paediatric urology.
The multicentre prospective clinical trial will be performed in partnership with three clinical sites across the NHS. The Department of Paediatric Urology at Southampton Children’s Hospital part of University Hospital Southampton NHS Foundation Trust; The Department of Paediatric Urology at Royal Manchester Children's Hospital part of Manchester University NHS Foundation Trust; and Department of Paediatric Urology, and the Evelina London Children’s Hospital, part of Guy’s and St Thomas’ NHS Foundation Trust.
Robotic surgery represents a capital-intensive segment that must comply with stringent regulatory requirements regarding clinical safety and efficacy demonstrated in clinical trials. By using Ledidi Core, CMR is able to develop and validate a data platform while saving time and reducing cost compared to the traditional approaches, such as outsourcing to Clinical Research Organisations (CROs).
Ledidi Core has an intuitive user interface, and CMR designed and set up the EDC and electronic case report forms (eCRF) themselves with minimal support from Ledidi. This provides a framework and a template that can be reused for future trials, which will save time and further improve the cost-effectiveness.
Mark Slack, Chief Medical Officer & Co-founder, CMR Surgical commented: “We are thrilled to have commenced the world’s first paediatric trial using Versius to support more patients to benefit from robotic-assisted minimal access surgery. We are committed to the responsible introduction of Versius across new specialties and data-driven clinical practice is integral to this, particularly in a trial setting. We look forward to working with Ledidi as we undertake this clinical trial to ensure the safety and efficacy of Versius in paediatrics.”
Strategic collaboration
In 2023, Ledidi and CMR formed a strategic collaboration to promote the value of clinical registries in the adoption of robotic surgery across surgical specialties, and to promote the importance of data-driven clinical practice for the improvement of quality of care and patient outcomes. This trial represents an extension of this partnership.
"We are delighted to see our collaboration with CMR Surgical expand to include clinical trials. Ledidi Core’s user-friendly interface and data management capabilities are designed to support such pivotal studies. At Ledidi, we believe in the power of data-driven clinical practice to improve patient outcomes and foster innovation in healthcare. Our partnership with CMR Surgical is a testament to this vision," says Dr Einar Martin Aandahl, Chief Executive Officer and co-founder of Ledidi, who is also a medical doctor and surgeon.
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