Montefiore Medical Center, Centennial Women's Center, Bronx, New York (Dr. Levie).
Stamford Health/Columbia University Medical School, Stamford, Connecticut (Dr. Chudnoff).
J Minim Invasive Gynecol. 2019 May-Jun;26(4):679-687. doi: 10.1016/j.jmig.2018.07.012. Epub 2018 Jul 21.
To evaluate the safety and effectiveness of the AEGEA Vapor System (Aegea Medical System, Menlo Park, CA) for the treatment of heavy menstrual bleeding (HMB).
A prospective, multicenter, single-arm, open-label, clinical trial. Follow-up assessments were conducted at 24 hours; 2 weeks; and 3, 6, and 12 months after the endometrial ablation procedure (Canadian Task Force Classification II-1).
A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands.
One hundred fifty-five premenopausal women aged 30 to 50years with HMB as determined by a pictorial blood loss assessment score ≥150. Preoperative evaluation included ultrasound, sonohysterography or hysteroscopy, and endometrial biopsy. Screening inclusion allowed treatment of up to 12-cm uterine sound lengths and nonobstructing myomata.
Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015.
The primary effectiveness end point was the reduction of menstrual blood loss to a pictorial blood loss assessment score ≤75. Success was judged based on the Food and Drug Administration's objective performance criteria, derived from the success rates of the first 5 global endometrial ablation pivotal clinical trials. The secondary effectiveness end points included quality of life and patient satisfaction as assessed using the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score as well as the need for surgical or medical intervention to treat abnormal bleeding at any time within the first 12 months after treatment. All adverse events, including device- and procedure-related events, were recorded. At 12 months, the primary effectiveness end point was achieved in 78.7% of subjects exceeding the OPC (p = .0004); 90.8% of subjects were satisfied or very satisfied with the treatment. Ninety-nine percent of subjects showed improvement in quality of life scores with an average decrease in the Menorrhagia Impact Questionnaire score by 8.1, 72% had less dysmenorrhea, and 85% of women whose sex lives were affected by their menses reported improvement in their sex lives. There were no reported serious adverse device effects or any reported serious adverse events that were procedure related.
The AEGEA Vapor System is a safe, effective, and minimally invasive option for performing in-office endometrial ablation under minimal anesthesia for the purpose of treating women who suffer from HMB.
评估 AEGEA Vapor 系统（Aegea Medical System，加利福尼亚州门洛帕克）治疗月经过多（HMB）的安全性和有效性。
前瞻性、多中心、单臂、开放性、临床试验。在子宫内膜消融术后 24 小时；2 周；以及 3、6 和 12 个月进行随访评估（加拿大任务组分类 II-1）。
美国、加拿大、墨西哥和荷兰的 15 个地点的私人诊所和门诊及住院环境。
155 名年龄在 30 至 50 岁之间的绝经前妇女，根据图片出血评估评分≥150 确定为 HMB。术前评估包括超声、子宫超声造影或宫腔镜检查和子宫内膜活检。筛查纳入允许治疗长达 12 厘米的子宫音长度和非阻塞性肌瘤。
在 2014 年 9 月至 2015 年 5 月期间，根据不同的麻醉方案使用蒸汽系统进行子宫内膜消融（120 秒治疗时间）。
主要有效性终点是将月经出血量减少到图片出血评估评分≤75。成功的判断基于食品和药物管理局的客观性能标准，该标准源自前 5 项全球子宫内膜消融关键临床试验的成功率。次要有效性终点包括使用 Menorrhagia Impact Questionnaire 和 Aberdeen Menorrhagia Severity Score 评估的生活质量和患者满意度，以及在治疗后 12 个月内任何时候因异常出血而需要手术或医疗干预的情况。记录所有不良事件，包括与设备和程序相关的事件。在 12 个月时，超过 OPC 的受试者中有 78.7%达到主要有效性终点（p=0.0004）；90.8%的受试者对治疗感到满意或非常满意。99%的受试者生活质量评分有所改善，Menorrhagia Impact Questionnaire 评分平均降低 8.1，72%的受试者痛经减轻，85%的性生活受月经影响的女性报告性生活改善。未报告严重不良设备效应或任何与程序相关的严重不良事件。
AEGEA Vapor 系统是一种安全、有效、微创的选择，可在最低限度的麻醉下进行门诊子宫内膜消融，用于治疗患有 HMB 的女性。
