Channel Medsystems completes pivotal study of Cerene® Cryotherapy Device for successful office based Endometrial ablation.

Cerene® Cryotherapy Device screenshot 

Channel Medsystems, a company based at Emeryville, CA announced the successful completion of the treatment phase in its CLARITY Pivotal Study. The pivotal study evaluated the safety and efficacy of Cerene® Cryotherapy Device in 242 women with heavy menstrual bleeding who have already completed the family.

Clarity study was a multisite study involving 8 locations in US along with few international locations. The study recruited its first participant in October 2016 and completed the study in just 5 months in early March 2017. The trial examined  parameters of comfort, recovery time and uterine healing for women undergoing  procedure.

The study participants were very enthusiastic about the treatment plan because the Cerene device, is designed to address women’s need for an effective, comfortable, office-based treatment with minimal to no downtime after the procedure.

Cerene® Cryotherapy Device screenshot

Cerene® Cryotherapy Device screenshot

“The Cerene cryoablation is a convenient, simple, and well-tolerated office procedure,” said Dr. Ted Anderson, Director of the Division of Gynecology at Vanderbilt University Medical Center and Investigator in the CLARITY study. “A patient can have this treatment the same way she has an IUD placed – in her gynecologist’s office with minimal pain management and very little discomfort. This has the potential to be a real game-changer for ablation.”

All women in the study were awake and responsive during the procedure, in contrast to heat ablation, allowing the investigators to collect data on pain scores throughout the therapy.

The Cerene Cryotherapy Device uses extreme cold to destroy tissue thereby reducing scarring and intrauterine adhesions that are often associated with heat-based treatments. Scarring and adhesions often lead to failure of procedure and reoperation. The cryothermic  delivery system was incorporated into disposable, ergonomic device that can be held by hands thereby eliminating bulky equipments.

The initial studies were presented  at 42nd American Association of Gynecologic Laparoscopists (AAGL)  Global Congress in Washington, D.C. in 2013. The subjects of initial studies were women who were scheduled for hysterectomy. The studies show that Channel Medsystems’ cryothermic therapy had an acceptable safety profile, can be performed in a clinically appropriate timeframe and was well-tolerated by the subject without the need for general anesthesia or conscious sedation.

The histopathogy specimen of the removed uteri showed selective   depth of ablation for  uterine cavity , cornua and lower uterine segment without compromising the function of uterine tissue. The results were parallel to currently-available hyperthermic therapies.

“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,” lead investigator Dr. Jose Leal of Monterrey, Mexico’s Universidad Autónoma de Nuevo León said in a prepared statement.

This device is limited to investigational use in the US, Canada, and Mexico.

For more information visit the website www.channel medsystems.com.

        Channel Medsystems endometrial cryoablation procedure animation video

source: http://www.channel medsystems.com