Endometrial ablation with NovaSure™ GEA, a pilot study

Abstract

Objective. A prospective, single-arm, multicenter, controlled, observational pilot study to assess the safety and efficacy of the NovaSure™ Global Endometrial Ablation (NovaSure™ 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 12months 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 6months follow-up and 58% had complete cessation of uterine bleeding (amenorrhea) at 12months follow-up. Conclusions. Preliminary results indicates that the NovaSure GEA System is an effective treatment for DUB, achieving 58% amenorrhea after 12months.