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

• Published in: Journal of minimally invasive gynecology Vol. 26; no. 4; p. 679
• Main Authors: Levie, Mark D, Chudnoff, Scott G
• Format: Journal Article
• Language: English
• Published: United States 01.05.2019
• Subjects: Endometrial ablation; Global endometrial ablation; Hysteroscopy; Heavy menstrual bleeding; AEGEA; Abnormal uterine bleeding

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...