A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

Autor:	Laberge P; Laval University, Department of Obstetrics and Gynecology, Quebec City, Quebec, Canada. Electronic address: philippe.laberge@fmed.ulaval.ca., Garza-Leal J; Universidad Autonoma de Nuevo Leon, Department of Obstetrics and Gynecology, Monterrey, NL, Mexico., Fortin C; Hôpital de LaSalle, Department of Obstetrics and Gynecology, LaSalle, Quebec, Canada., Grainger D; The Center for Reproductive Medicine, Wichita, Kansas., Johns DA; Baylor All Saints Medical Center, Department of Obstetrics and Gynecology, Fort Worth, Texas., Adkins RT; Tennessee Women's Care, Nashville, Tennessee., Presthus J; Minnesota Gynecology & Surgery, Edina, Minnesota., Basinski C; Evansville OB/GYN, Newburgh, Indiana., Swarup M; New Horizons Women's Care Branch of Arizona Ob/Gyn Affiliates, Chandler, Arizona., Gimpelson R; Mercy Hospital, Department of Obstetrics and Gynecology, St. Louis, Missouri., Leyland N; McMaster University, Department of Obstetrics and Gynecology, Hamilton, Ontario, Canada., Thiel J; University of Saskatchewan, Department of Obstetrics and Gynecology, Regina, Saskatchewan, Canada., Harris M; Women's Health Research, Phoenix, Arizona., Burnett PE; KCAS Bioanalytical & Biomarker Services, Shawnee, Kansas., Ray GF; KCAS Bioanalytical & Biomarker Services, Shawnee, Kansas.
Jazyk:	angličtina
Zdroj:	Journal of minimally invasive gynecology [J Minim Invasive Gynecol] 2017 Jan 01; Vol. 24 (1), pp. 124-132. Date of Electronic Publication: 2016 Sep 26.
DOI:	10.1016/j.jmig.2016.09.009
Abstrakt:	Study Objective: To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women. Design: Multicenter, randomized, controlled, international study (Canadian Task Force classification I). Setting: Thirteen academic and private medical centers. Patients: Premenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O). Intervention: Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation. Measurements and Main Results: At 1-year post-treatment, study success (alkaline hematin ≤80 mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1 minutes for Minerva and 17.2 minutes for rollerball. There were no intraoperative adverse events and/or complications reported. Conclusion: The results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures. (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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