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

Mark D. Levie, Scott G. Chudnoff

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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). Design: 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). Setting: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. Patients: One hundred fifty-five premenopausal women aged 30 to 50 years 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. Interventions: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. Measurements and Main Results: 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. Conclusion: 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.

Original languageEnglish (US)
JournalJournal of Minimally Invasive Gynecology
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Endometrial Ablation Techniques
Multicenter Studies
Menorrhagia
Safety
Hemorrhage
Anesthesia
Quality of Life
Clinical Trials
Therapeutics
Hysteroscopy
Equipment and Supplies
Myoma
Dysmenorrhea
Private Hospitals
Menstruation
Private Practice
Advisory Committees
United States Food and Drug Administration
Mexico
Patient Satisfaction

Keywords

  • Abnormal uterine bleeding
  • AEGEA
  • Endometrial ablation
  • Global endometrial ablation
  • Heavy menstrual bleeding
  • Hysteroscopy

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

@article{90a09bcf346d42d78be7291e5cf3a620,
title = "A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System",
abstract = "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). Design: 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). Setting: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. Patients: One hundred fifty-five premenopausal women aged 30 to 50 years 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. Interventions: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. Measurements and Main Results: 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. Conclusion: 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.",
keywords = "Abnormal uterine bleeding, AEGEA, Endometrial ablation, Global endometrial ablation, Heavy menstrual bleeding, Hysteroscopy",
author = "Levie, {Mark D.} and Chudnoff, {Scott G.}",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.jmig.2018.07.012",
language = "English (US)",
journal = "Journal of Minimally Invasive Gynecology",
issn = "1553-4650",
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T1 - A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System

AU - Levie, Mark D.

AU - Chudnoff, Scott G.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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). Design: 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). Setting: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. Patients: One hundred fifty-five premenopausal women aged 30 to 50 years 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. Interventions: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. Measurements and Main Results: 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. Conclusion: 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.

AB - 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). Design: 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). Setting: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. Patients: One hundred fifty-five premenopausal women aged 30 to 50 years 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. Interventions: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. Measurements and Main Results: 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. Conclusion: 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.

KW - Abnormal uterine bleeding

KW - AEGEA

KW - Endometrial ablation

KW - Global endometrial ablation

KW - Heavy menstrual bleeding

KW - Hysteroscopy

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