Channel Medsystems has treated first subject in a study to assess the safety and effectiveness of the Cerene Cryotherapy Device for endometrial ablation in women with heavy menstrual bleeding who are finished with childbearing.
Apart from showing the effectiveness in controlling heavy bleeding, the CLARITY Study has been designed to demonstrate outcomes several key parameters such as patient comfort, recovery time and uterine healing.
The Cerene device has been designed and engineered, keeping patient comfort in mind. This is quite contrary to the conventional heat-based endometrial ablation technologies available today. The study of the device is presently limited to US, Canada and Mexico, with several clinical sites.
The company claims that the cryothermic energy can reduce scarring and intrauterine adhesions which are associated with heat-based endometrial ablation, apart from providing analgesic effect.
Intrauterine scarring and adhesions could lead to long-term complications and ultimately the failure of endometrial ablation.
Channel Medsystmes says that the Cerene Cryotherapy Device has been developed after taking feedback from clinicians and biomedical engineers. The device works by using extreme cold for destroying tissue.
This system is a durable therapy often used to ablate malignant and benign cardiac, liver, breast and prostate tissue, among others.
The engineering team at the company had integrated the delivery system and user controls into a disposable, self-contained, handheld device, removing the need for capital equipment.
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.”
Monterrey, Mexico-based, Universidad Autónoma de Nuevo León Investigator Dr. Jose Garza Leal said: “Cerene is different from other endometrial ablation technologies I routinely use.
“Unlike current heat-based ablation devices, my patients actually relaxed once the two-and-a-half-minute treatment was initiated. This was a completely different treatment experience for me, my patients, and my staff.”