Menorrhagia Abnormal Uterine Bleeding
Conditions
Interventions
Endometrial ablation is a minimally invasive treatment of menorrhagia that eliminates the the endometrial layer of the uterine cavity while preserving the uterus.
Sponsors
AEGEA Medical
2686 Middlefield Road, Suite A
Redwood City, California 94063
United States of America
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women of age ≥ 30 and ≤ 50 years; 2. Pre-menopausal (absence of hot flashes); 3. Monthly menstrual cycles (cycle days 21-35) over the last 6 months; 4. Self-reported history of heavy menstrual bleeding as noted by flooding or interfering with work or social activities in 3 months of the past 6 months; 5. Documented history of excessive uterine bleeding defined by: A. Alkaline hematin score of ≥ 160 mL for one month, within three months prior to the ablation procedure (this test may be repeated one time if the initial result is 120 mL); AND; B. Previously failed, did not tolerate or refused medical therapy (oral contraceptive pills, NSAIDs, failed D&C or cyclic progestin therapy). 6. Evidence of normal PAP smear, including Class II/ASCUS that has been evaluated, within the last 6 months; 7. Evidence of normal endometrial biopsy results within the last 6 months; 8. Not currently using any hormonal contraceptives (for example, oral or injectable) and have not been using any hormonal contraceptives for a minimum of three months prior to study enrollment, and agree to not use any hormonal contraceptives from the time of study enrollment through the first 12 months following treatment, OR Are currently using hormonal contraceptives, (for example, oral or injectable) and have been using hormonal contraceptives for a minimum of three months prior to study enrollment, and agree to continue to use hormonal contraceptives from the time of study enrollment through the first 12 months following treatment; 9. Are not currently taking any hormonal supplements (for example, estrogen) and have not been using any hormonal supplements for a minimum of three months prior to study enrollment and agree not to use hormonal supplements from the time of study enrollment through the first 12 months following treatment; 10. Do not desire current or future childbearing; 11. Not currently pregnant; 12. Do not desire to have an intrauterine device (IUD) placed or Essure or Adiana devices placed during the first 12 months following treatment m); 13. Agrees to use sponsor provided sanitary pads and tampons during the conduct of the Alkaline Hematin tests; 14. Able and willing to comply with all study tests, procedures and assessment tools; 15. Able and willing to sign the Informed Consent Form; 16. Agrees to follow up period as outlined.
Exclusion criteria
Exclusion criteria: 1. Hemoglobin 12 cm; 6. Submucosal myoma(s) > 4 cm diameter or that distort the uterine cavity; 7. Uterine and/or cervical polyps > 1 cm in diameter; 8. Intramural myomas that are > 4 cm in diameter or that distort the uterine cavity; 9. Bicornuate uterus; 10. Known or suspected hydrosalpinx; 11. Previous endometrial ablation procedure; 12. Desire for complete amenorrhea; 13. Known anatomical condition (e.g., history of previous classical cesarean section or transmural myomectomy, or uterine wall thickness < 1 cm) or pathologic condition that could lead to weakening of the myometrium; 14. Currently participating in another clinical trial; 15. The Investigator determines enrollment in the study is not appropriate for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary effectiveness endpoint is the reduction in menstrual blood loss as measured by an alkaline hematin score of < 80 mL at 3 months; 2. Procedural safety: Defined by the absence of device or procedure related serious adverse events within 14 days of the ablation procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's subjectively reported improvement based on 6 month post-procedure Multi-Attribute Utility Assessment (Menorrhagia Questionnaire) as compared to Baseline. | — |
Contacts
Public ContactAndreas Thurkow
St. Lucas Andreas Ziekenhuis J. Tooropstraat 164
Outcome results
None listed