Endometrial ablation with NovaSure™ GEA, a pilot study

Objective. A prospective, single-arm, multicenter, controlled, observational pilot study to assess the safety and efficacy of the NovaSure(TM) Global Endometrial Ablation (NovaSure(TM) GEA) system in women with severe menorrhagia secondary to dysfunctional uterine bleeding (DUB). Setting. University tertiary referring center and central hospital. Patients. Forty-six premenopausal women aged 41.3 years with menorrhagia secondary to DUB unresponsive to medical therapy, who had completed childbearing, with non-distorted uterine cavities were included in the study. Methods. Bleeding score was recorded before, 6 and 12 months after treatment. All patients received the treatment under intravenous sedation with para-cervical block and were treated with Nova Sure endometrial ablation for mean 94 s at the day surgery unit. Results. No serious intraoperative complications were observed. Treatment time averaged 94 s. Forty-six patients have completed 6-months of follow-up and 45 patients completed the 12-months follow-up. 50% of the patients were amenorrheic at 6 months follow-up and 58% had complete cessation of uterine bleeding (amenorrhea) at 12 months follow-up. Conclusions. Preliminary results indicates that the NovaSure GEA System is an effective treatment for DUB, achieving 58% amenorrhea after 12 months.