Ultrasound-guided transcervical radiofrequency ablation provides an effective, safe and minimally invasive alternative for the treatment of symptomatic uterine fibroids suggests the results of pivotal IDE trial published in the January issue of Obstetrics & Gynecology.
The prospective, longitudinal, multicenter Sonography-Guided Transcervical Fibroid Ablation (SONATA) trial evaluated Gynesonics's investigational Sonata system in the treatment of heavy menstrual bleeding (HMB) because of uterine leiomyomata.
The Sonata System combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure to treat symptomatic uterine fibroids.
The trial enrolled 147 premenopausal women between age 25-50 years with HMB for at least three months, across 22 centers in the United States and Mexico. The size and number of fibroids varied between 1 to 5 cm diameters and 1-10 fibroids per woman respectively.
All women were followed for 12 months and results assessed in terms of relief from heavy menstrual blood loss, device-related complications, and surgical intervention rate.
Scott Chudnoff, Chief of OB/GYN at Stamford Hospital, Stamford CT a principal investigator in the SONATA trial, said in a press release, “The actual results achieved in the SONATA trial far exceed the required thresholds established by the FDA for the co-primary endpoints of reduction in menstrual bleeding and freedom from surgical reintervention for bleeding. These results, along with the impressive levels of patient satisfaction and rapid return to normal activity achieved, clearly demonstrate the potential for Sonata as a first line treatment for symptomatic fibroids.”
At the end of follow-up period of 12 months, 99% of patients did not require any additional surgical intervention for controlling HMB, 94% of patients reported relief from substantial blood loss with 60% reporting a 50% reduction in the amount of blood loss.
There was minimal surgical downtime with half of them returning to regular activity the next day of surgery, and 97% were satisfied with the procedure. No device-related complications were reported.
Procedure-related adverse events reported include fibroid sloughing (30.6%), cramping or pain (7.5%), leukorrhea (6.1%), and uncomplicated genitourinary infections (4.8%).
The results of the study earned FDA clearance for the SONATA system in August 2018. The results were also consistent with the previously published FAST-EU trial. Chris Owens, President and CEO stated.
“Considering these two prospective, multicenter trials were comprised of several disparate patient populations across two continents and performed by a broad range of physician operators across various healthcare delivery systems, and clinical settings, the consistency of these results is remarkable. The reproducible results highlight the robustness of the Sonata platform design and its potential to become a new standard of care for fibroid treatment.”
“Considering these two prospective, multicenter trials were comprised of several disparate patient populations across two continents and performed by a broad range of physician operators across various healthcare delivery systems, and clinical settings, the consistency of these results is remarkable. The reproducible results highlight the robustness of the Sonata platform design and its potential to become a new standard of care for fibroid treatment.”
Gynesonics funded the study, and lead author have received travel and lodging expenses and honoraria for speaking for Gynesonics.
Here is a video showing SONATA system overview
