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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160047 / PAS001 |
| Study Name |
AEGEA Pivotal Clinical Study
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| Device Name |
AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The AEGEA Pivotal Clinical Trial (Protocol SE-3000) is a prospective, single-arm, non-randomized, multicenter, open label clinical trial to evaluate the safety and effectiveness of the AEGEA Vapor System™ for the treatment of excessive menstrual bleeding. Subjects were enrolled at fourteen investigational sites in the United States, Mexico, Canada, and The Netherland.
The AEGEA Pivotal Clinical Trial was divided into two groups: Safety subjects (or Safety cohort) and Pivotal subjects (or Pivotal cohort). Sixty-six (66) Safety subjects and 155 Pivotal subjects were evaluated. The primary analysis population for safety and effectiveness for this study was the Intent-to-Treat (ITT) population for the Pivotal subjects. Safety results from the Safety subjects were considered as part of the evaluation of device safety.
Data from the Pivotal cohort are the basis of effectiveness outcome analyses to support this PMA. Data from the Safety cohort is not included in the effectiveness analysis, but it is considered as a part of safety evaluation.
Follow-up of Pivotal cohort occurred at 24 hours post-procedure, 2 weeks and 3, 6, and 12 months post-procedure prior to PMA submission. The applicant intends to continue follow-up in the post-market setting to collect long-term outcome in Pivotal cohort at two and three years.
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| Study Population |
The demographics of the study population (Pivotal subjects) are typical for an endometrial ablation study performed in the United States. Seventy-six (76) patients were 30-39 years old, and seventy-nine (79) patients were 40-50 years old. The mean age of subjects at baseline was 39.8. An evaluation of these data confirmed the data could be pooled across sites and countries.
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| Sample Size |
One hundred and thirty-seven (137) of 155 Pivotal subjects enrolled in the premarket study are available for postmarket follow-up.
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| Key Study Endpoints |
Need for surgical or medical intervention to treat abnormal bleeding
Subject self-report of pregnancy
Contraception status (data to be collected at 3 years only)
Menstrual status
Gynecologic adverse events
Quality of Life questionnaire
Patient satisfaction
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| Follow-up Visits and Length of Follow-up |
Three years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
155
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| Actual Number of Sites Enrolled |
14
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| Patient Follow-up Rate |
12-month: 91.0% (141/155)
24-month: 98.5% (133/137)
36-month: 91.2% (125/137)
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| Final Safety Findings |
There were 54 adverse events from 12 months to 36 months, including eight (8) serious adverse events (SAEs) and 46 non-serious adverse events. Of the eight (8) SAEs, one (hematometra) was related to the procedure. There were no unanticipated device-related adverse events in the study through the 3-year follow-up.
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| Final Effect Findings |
Premarket effectiveness endpoints: The overall success rate based on PBLAC results was 78.7% (122/155) at 12 months. The amenorrhea (no menses) rate was 19.4% (30/155).
Postmarket effectiveness endpoints:
Need for surgical or medical intervention to treat abnormal bleeding: From 12 to 36 months, 6.8% subjects (9/133) had medical or surgical intervention to treat abnormal menstrual bleeding.
Subject self-report of pregnancy: None
Quality of Life: The Menorrhagia Impact Questionnaire (MIQ) score (mean +/- SD) was reduced from 14.7 +/- 2.9 (baseline) to 6.1 +/- 1.7 (n=133) at 24 months and 6.3 +/- 1.9 (n = 125) at 36 months.
Patient Satisfaction: The percentages of patients reporting very satisfied or satisfied were 90% (118/132) at 24 months and 91% (114/125) at 36 months. The percentages of patients who would recommend the ablation procedure to a friend were 92% (122/132) at 24 months and 94% (118/125) at 36 months.
Contraception Status:
Method of Contraception 36 Month (N=127*)
Surgical Tubal Ligation 64 (50%)
Vasectomy 29 (23%)
Barrier 21 (17%)
Implantable (Essure) 6 (5%)
Abstinence 3 (2%)
None 2 (2%)
Other (sterile subject; salpingectomy) 2 (2%)
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| Study Strengths & Weaknesses |
n/a
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| Recommendations for Labeling Changes |
The sponsor submitted P160047/S006 to request labeling changes based on the 24 and 36-month follow up from this pivotal study.
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