Channel Medsystems has started the US phase of its CLARITY Pivotal Study of the Cerene Cryotherapy Device for the treatment of heavy menstrual bleeding.
The device has been developed for endometrial ablation in women with heavy menstrual bleeding who will not conceive.
The non-surgical device removes the inner lining of the uterus by using controlled cryotherapy (freezing) technology, perfomed at the doctor's office.
Cryoablation is a well-characterised, durable therapy where extreme cold is used to destroy tissue in order to ablate malignant and benign cardiac, liver, breast, and prostate tissue, among others.
The Cerene device uses cryothermic energy to reduce the likelihood of scarring and intrauterine adhesions that are often associated with heat-based endometrial ablation which may lead to long-term complications and failure of endometrial ablation.
The Clarity study has been designed to demonstrate the safety and efficacy of the Cerene Cryotherapy Device while also assessing some important factors such as patient comfort, recovery time, and uterine healing.
Channel Medsystems president and CEO Ric Cote said: "We expect that the CLARITY study will confirm that the Cerene device can support a comfortable procedure without the need for IV sedation or narcotic pain medication.
"This is the first endometrial ablation technology that was designed to deliver reproducible, successful outcomes in the comfort of the physician's office a lower-cost setting of care that both women and gynecologists prefer."