title: Analysis of the safety and reliability of a hydrothermal ablation system: a multicenter, prospective postmarket study.
abstract: OBJECTIVE
  To obtain information on practitioner experience in the use of the Genesys HydroThermAblator (HTA) System under normal clinical conditions through documentation of the system's acute safety features, in terms of burn rates, and its technical reliability.
  
  
  METHODS
  This was a prospective, observational, multicenter, postmarket interventional clinical trial with outcome measures of acute (within 21 days post-procedure) safety, serious adverse device effects, and technical malfunctions in a population of premenopausal women > or = 18 years of age.
  
  
  RESULTS
  A total of 992 women (mean age, 41.7 +/- 6.8 years; range, 22-65 years) were enrolled in 18 clinical sites throughout the United States. The Genesys HTA System provided low burn rates in the intent-to-treat (n = 992 [0.4%] [95% CI 0.1-1.0%]) and evaluable (n = 931 [0.2%] [95% CI 0.1-0.8%]) subject populations. Only 1 burn was clinically significant and was defined as a serious adverse device effect (1/992 [0.10%] [95% CI 0.0-0.6%]). Fifty-three (5.1%) technical malfunctions occurred in 44 procedures, and 27 (27/44 [61.4%]) patients completed their procedures after 31 (31/ 53 [58.5%]) technical problems were addressed and resolved.
  
  
  CONCLUSIONS
  The Genesys HTA System delivers a safe and reliable treatment option for premenopausal women with heavy menstrual bleeding.
authors.forename: Jay M
authors.initials: JM
authors.lastname: Berman
authors.forename: David P
authors.initials: DP
authors.lastname: Krewson
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Livingston
authors.forename: Doreen
authors.initials: D
authors.lastname: Moser
authors.forename: Melanie K
authors.initials: MK
authors.lastname: Schultz
mesh_terms: D000328:Adult; D000368:Aged; D002056:Burns / Q000453:epidemiology / Q000209:etiology*; D055356:Endometrial Ablation Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D004717:Endometrium / Q000601:surgery*; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007431:Intraoperative Complications / Q000453:epidemiology / Q000209:etiology; D008595:Menorrhagia / Q000601:surgery*; D008875:Middle Aged; D017697:Premenopause; D011358:Product Surveillance, Postmarketing; D012449:Safety; D014481:United States / Q000453:epidemiology