Women’s healthcare firm Gynesonics has completed patient enrollment in its investigational device exemption (IDE) clinical trial of Sonata system for incision free treatment of symptomatic uterine fibroids.
The trial, which is approved by the US Food and Drug Administration (FDA), is a prospective, longitudinal and multi-center study that will assess the safety and effectiveness of the investigational Sonata system to treat women with heavy menstrual bleeding symptoms due to fibroids.
Gynesonics recruited 147 patients at 22 centers in the US and Mexico. The trial’s primary endpoints include the reduction of bleeding and incidence of surgical reintervention, both at 12 months after completion of the procedure.
Part of the firm’s next generation fibroid treatment platform, the Sonata system uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance.
It features Smart Targeting Guide that allows the operator to target and ablate fibroids
Sonata procedure includes the transcervical delivery of a single integrated handpiece combining intrauterine sonography guidance with radiofrequency ablation.
Gynesonics said that it is the only firm in the world with an intrauterine ultrasound imaging and guidance technology platform.
Gynesonics president and CEO Christopher Owens said: “We are pleased to have completed the patient enrollment in the Sonata pivotal trial ahead of schedule.
“There is a significant unmet need for an incision free, uterus-preserving option for the treatment of symptomatic uterine fibroids.”
The company plans to complete the required follow up and submit the results to FDA in a 510(k) submission during the fourth quarter of 2017.