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.
To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women.



Multicenter, randomized, controlled, international study (Canadian Task Force classification I).



Thirteen academic and private medical centers.



Premenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O).



Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation.



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.



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.
Laval University, Department of Obstetrics and Gynecology, Quebec City, Quebec, Canada. Electronic address: philippe.laberge@fmed.ulaval.ca.
Philippe
P
Laberge
Universidad Autonoma de Nuevo Leon, Department of Obstetrics and Gynecology, Monterrey, NL, Mexico.
Jose
J
Garza-Leal
Hôpital de LaSalle, Department of Obstetrics and Gynecology, LaSalle, Quebec, Canada.
Claude
C
Fortin
The Center for Reproductive Medicine, Wichita, Kansas.
David
D
Grainger
Baylor All Saints Medical Center, Department of Obstetrics and Gynecology, Fort Worth, Texas.
Delbert Alan
DA
Johns
Tennessee Women's Care, Nashville, Tennessee.
Royce T
RT
Adkins
Minnesota Gynecology & Surgery, Edina, Minnesota.
James
J
Presthus
Evansville OB/GYN, Newburgh, Indiana.
Cindy
C
Basinski
New Horizons Women's Care Branch of Arizona Ob/Gyn Affiliates, Chandler, Arizona.
Monte
M
Swarup
Mercy Hospital, Department of Obstetrics and Gynecology, St. Louis, Missouri.
Richard
R
Gimpelson
McMaster University, Department of Obstetrics and Gynecology, Hamilton, Ontario, Canada.
Nicholas
N
Leyland
University of Saskatchewan, Department of Obstetrics and Gynecology, Regina, Saskatchewan, Canada.
John
J
Thiel
Women's Health Research, Phoenix, Arizona.
Micah
M
Harris
KCAS Bioanalytical & Biomarker Services, Shawnee, Kansas.
Pamela E
PE
Burnett
KCAS Bioanalytical & Biomarker Services, Shawnee, Kansas.
Gene F
GF
Ray
D000328:Adult; D055356:Endometrial Ablation Techniques / Q000009:adverse effects* / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015907:Hysteroscopy / Q000009:adverse effects / Q000379:methods; D008595:Menorrhagia / Q000601:surgery*; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects / Q000379:methods; D017060:Patient Satisfaction; D017697:Premenopause; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
Endometrial ablation; HMB; Heavy menstrual bleeding; Hysteroscopy; Minerva endometrial ablation system; Rollerball