Dune Medical Devices has started the clinical and economic study of its MarginProbe breast-cancer surgical assessment device.
The firm has recruited first patients in the UK’s National Institute of Health Research (NIHR) subdivision of the National Health Service (NHS) sponsored research study.
MarginProbe is claimed to be the first and only FDA-approved technology, which allows surgeons to detect cancer at the surface of excised tissue specimens during surgery.
The University Hospital of Southern Manchester surgical oncology professor Dr Nigel Bundrud is the principal investigator of the trial, which will investigate whether inter-operative use of the MarginProbe device reduces the need for further re-excision procedures after conservation surgery for breast cancer.
It is a randomized, prospective and double arm study that includes around 460 patients at six breast unit specialty sites across the UK.
The trial is said to monitor the number of patients who require additional surgery nine months of the initial procedure while also comparing a patient’s quality of life and cosmetic outcomes.
Dune president Dan Hashimshony said: "We are excitedly optimistic for the results of the NHS study. There have been a number of recent research studies that found surgeons who use MarginProbe during lumpectomies have best chance of getting all the cancer during the first surgery.
"Getting clean margins in one surgery moves a patient through to recovery more quickly giving them the best possible surgical and cosmetic outcome and ultimately reduces the economic impact."