A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System

Levie Mark D.; Chudnoff Scott G.

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A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System

机译：一种预期，多中心，枢轴试验，以评估AegeA蒸汽子宫内膜消融系统的安全性和有效性

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摘要

Study Objective: 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).

机译：研究目的：评价Aegea蒸气系统（AEGEA医疗系统，MENLO PARK，CA）的安全性和有效性治疗重重经理出血（HMB）。

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来源
《Journal of minimally invasive gynecology》 |2019年第4期|共9页
作者
Levie Mark D.; Chudnoff Scott G.;
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作者单位

Montefiore Med Ctr Centennial Womens Ctr 3332 Rochambeau Ave Bronx NY 10467 USA;

Columbia Univ Sch Med Stamford Hlth Stamford CT USA;

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原文格式 PDF
正文语种 eng
中图分类妇产科学;
关键词
Endometrial ablation; Abnormal uterine bleeding; Global endometrial ablation; AEGEA; Hysteroscopy; Heavy menstrual bleeding;

机译：子宫内膜消融;异常子宫出血;全球子宫内膜消融;AEGEA;宫腔镜检查;大量的月经出血;

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专利

1. A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System [J] . Levie Mark D., Chudnoff Scott G. Journal of minimally invasive gynecology . 2019,第4期

机译：一种预期，多中心，枢轴试验，以评估AegeA蒸汽子宫内膜消融系统的安全性和有效性
2. 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 Response [J] . Laberge Philippe Journal of minimally invasive gynecology . 2017,第4期

机译：随机对照多中心美国食品和药物管理试验Minerva子宫内膜消融系统的安全性和疗效：一年的后续结果响应
3. 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 [J] . Laberge Philippe, Garza-Leal Jose, Fortin Claude, Journal of minimally invasive gynecology . 2017,第1期

机译：随机对照多中心美国食品和药物管理试验Minerva子宫内膜消融系统的安全性和有效性：一年的后续结果
4. Effectiveness of various regimens of maintaining anti-inflammatory therapy in mild to moderate asthmatic children: results of the prospective multicenter randomized trial [C] . Tereshchenko S., Smirnova S., Novitckii I., World Asthma, Allergy COPD Forum . 2014

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5. Prospective Phase II Multicenter Registry of Ablation after Breast Lumpectomy Added to Extend (ABLATE) Intraoperative Margins in the Treatment of Breast Cancer [D] . Klimberg, V. Suzanne. 2017

机译：乳房肿块切除术后消融的前瞻性II期多中心消融术增加了扩大（ABLATE）术中切缘在治疗乳腺癌中的作用
6. Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective Multicenter Pivotal Clinical Trial [O] . Nicholas Leyland, Micah Harris 2021

机译：用于重症月经出血的水蒸汽子宫内膜消融：36个月的前瞻性多中心临床临床试验
7. Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding [O] . D. Alan Johns, Jose G. Garza-Leal, Michael P. Diamond, 2020

机译：后消融腔评估：预期多中心观察临床研究，评价水蒸汽子宫内膜消融治疗重重经济出血的水蒸汽子宫内膜消融4年后宫腔镜腔室

A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System

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