title: One-Year Follow-Up Results of a Multicenter, Single-Arm, Objective Performance Criteria-Controlled International Clinical Study of the Safety and Efficacy of the Minerva Endometrial Ablation System.
abstract: OBJECTIVE
  To assess the safety and effectiveness of the Minerva endometrial ablation system for treating excessive uterine bleeding in premenopausal women.
  
  
  METHODS
  Multicenter, single-arm, objective performance criteria (OPC)-controlled international study (Canadian Task Force classification II-1).
  
  
  METHODS
  Seven academic medical centers.
  
  
  METHODS
  105 premenopausal women symptomatic for menorrhagia secondary to dysfunctional uterine bleeding.
  
  
  METHODS
  Patients were treated using the Minerva endometrial ablation system.
  
  
  RESULTS
  Study success, based on a pictorial blood loss assessment chart (PBLAC) score ≤75, was observed in 96.2% of the patients at 1 year posttreatment. Some 69.5% of the patients experienced amenorrhea (PBLAC score 0). The mean duration of the procedure was 3.9 minutes. General anesthesia was used in 9% of cases, with the balance being performed under local and/or intravenous or spinal anesthesia regimens. No intraoperative adverse events and/or complications were reported. No patient required hysterectomy or any additional medical and/or surgical interventions to control bleeding during 1 year of follow-up. Efficacy (success) results were compared between the Minerva system and the OPC, which served as a statistical control. The OPC comprised the US Food and Drug Administration's (FDA) reported success rates of all FDA-approved endometrial ablation systems. The Minerva system had a statistically significantly superior success rate compared with the OPC control.
  
  
  CONCLUSIONS
  The Minerva system was found to be safe and effective for treating patients suffering from menorrhagia. The procedure is quick and effective, does not require endometrial pretreatment, and precludes the need for additional surgical interventions to manage menorrhagia.
authors.affiliation: Department of Obstetrics and Gynecology, Laval University, Quebec City, QC, Canada. Electronic address: philippe.laberge@fmed.ulaval.ca.
authors.forename: Philippe
authors.initials: P
authors.lastname: Laberge
authors.affiliation: Department of Obstetrics and Gynecology, Universidad Autonoma de Nuevo Leon, Monterrey, NL, Mexico.
authors.forename: Jose
authors.initials: J
authors.lastname: Garza-Leal
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital de LaSalle, LaSalle, QC, Canada.
authors.forename: Claude
authors.initials: C
authors.lastname: Fortin
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital du Sacre-Coeur de Montreal, Montreal, QC, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Sabbah
authors.affiliation: Department of Obstetrics and Gynecology, Szent Imre Kórház, Budapest, Hungary.
authors.forename: Tamas
authors.initials: T
authors.lastname: Fulop
authors.affiliation: Department of Obstetrics and Gynecology, University of Szeged, Szent-Györgyi Albert Medical Center, Szeged, Hungary.
authors.forename: Norbert
authors.initials: N
authors.lastname: Pásztor
authors.affiliation: Department of Obstetrics and Gynecology, Kenezy Korház, Debrecen, Hungary.
authors.forename: György
authors.initials: G
authors.lastname: Bacsko
mesh_terms: D000328:Adult; D055356:Endometrial Ablation Techniques / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008796:Metrorrhagia / Q000209:etiology / Q000601:surgery*; D008875:Middle Aged; D017697:Premenopause; D016896:Treatment Outcome; D014481:United States
keywords: Dysfunctional uterine bleeding; Endometrial ablation; Excessive menstrual bleeding; Hysteroscopy; Menorrhagia; Minerva Surgical; Objective performance criteria; Pictorial blood loss assessment chart