Use of the NovaSure Impedance Controlled Endometrial Ablation System in patients with intracavitary disease: 12-month follow-up results of a prospective, single-arm clinical study.

STUDY

OBJECTIVE

To assess the safety and effectiveness of the NovaSure Impedance Controlled Endometrial Ablation System for the treatment of excessive uterine bleeding in premenopausal and postmenopausal women with intracavitary disease (polyps or myomas) up to 3 cm.

DESIGN

Prospective, single-arm study. (Canadian Task Force Classification II-2.)

SETTING

Academic medical center.

PATIENTS: This clinical study was conducted in 65 women with menometrorrhagia with confirmed (type I and II) submucous myomas up to 3 cm with and without polyps.

INTERVENTION: Patients were treated with the NovaSure System and received no hormonal or mechanical pretreatment to thin the endometrial lining or as a uterine pathologic condition shrinking agent.

MEASUREMENTS AND MAIN

RESULTS

All patients were diagnosed with intracavitary disease during office hysteroscopy. Patients completed menstrual questionnaires at the initial screening and at 1 year after treatment. Twelve-month results demonstrated that the NovaSure System was effective in reducing excessive uterine blood loss. Success (defined as reduction to normal bleeding) was observed in 95% (95% CI: 86%-99%) of patients, with 69% (95% CI: 56%-80%) reporting amenorrhea at 1 year after treatment. The median treatment time (time of energy delivery) was 78 seconds (range 61-120 seconds). All patients underwent the procedure under local or intravenous sedation. No intraoperative or postoperative adverse events were reported. There was a significant decrease in premenstrual symptoms and dysmenorrhea at 12 months after the procedure. Ninety-five percent (95% CI: 86%-99%) of patients were satisfied with the procedure.

CONCLUSION

Clinical results of this study demonstrate that the NovaSure System is safe and effective in treatment of patients with menometrorrhagia caused by intracavitary disease up to 3 cm.