A prospective, multicenter clinical trial to evaluate the safety and the effectiveness of the AEGEA Vapor System* for the treatment of excessive uterine bleeding.

1. Able to understand and has voluntarily signed and dated the IRB/EC approved informed
consent form (ICF) prior to initiation of any screening or study-specific procedures;
2. Female subject from (and including) age 30 to 50 years;
3. Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months prior to
screening;
4. Predictable cyclic menstrual cycles (consistent cycle duration days 21-35 days) over the
last 6 months;
5. Excessive uterine bleeding, as documented by the Pictorial Blood Loss Assessment
Chart (PBLAC), with a PBLAC score of *150 for one baseline cycle within three months
prior to the endometrial ablation procedure for women who:
* Had at least 3 prior months (documented) failed medical therapy; or
* Had a contraindication to medical therapy (e.g., oral contraceptive pills, NSAIDs,
failed D&C, iron, cox inhibitors, tranexamic acid, progestins); or
* Intolerant of medical therapy; or
* Refused medical therapy.
6. Pre-menopausal at enrollment as determined by FSH measurement *40 IU/L;
7. Normal PAP or ASCUS PAP with negative HR HPV, within the past year or at the time of
screening or ASCUS HPV positive/low grade SIL who have been appropriately evaluated
and managed;
8. Normal endometrial biopsy within the past 3 months or at the time of screening;
9. Willing to use reliable contraception through the initial 12 month time period following the
AEGEA endometrial ablation procedure. Acceptable methods include:
* Female surgical sterilization (bilateral tubal sterilization), if completed prior to
enrollment in the study
* Implantable contraceptive device (e.g., Essure® Birth Control or Adiana®
Permanent Contraception System) if the tubal occlusion confirmation test has
been completed and is satisfactory prior to enrollment in this study;
Vasectomy with semen analysis confirming no sperm present (based on subject
report) and subject has a stable monogamous relationship throughout the initial
12 month follow-up phase
* Barrier contraceptives combined with spermicidal agent
* Monthly cyclic hormonal contraception (allowing a monthly withdrawal period) if
the subject has used monthly cyclic hormonal contraception for *3 months prior
to enrollment and is willing to continue the same monthly cyclic hormonal
contraception through the initial 12 month follow-up phase. Note: subjects not
on monthly cyclic hormonal contraceptives for a minimum of 3 months prior to
enrollment must agree to not use any monthly cyclic hormonal contraceptive from
enrollment through the initial 12 month follow-up phase except for the use of
endometrial thinning agents prior to the endometrial ablation procedure.
However, such subjects must agree to use another acceptable method of birth
control as outlined above.
NOTE: Other than for purposes of endometrial thinning prior to the ablation procedure,
subjects must not use hormonal contraception continuously (in order to suppress the
menstrual cycle and thus not allow a withdrawal bleed) for the concomitant treatment of
menorrhagia. There should be no concomitant use of any medication intended to treat
menorrhagia.
10. Not currently taking any hormonal medication (e.g., estrogen, progestin) and have not
been using any hormonal medication for a minimum of three months prior to study
enrollment and agree not to use hormonal medication from the time of study enrollment
through the initial 12 month follow-up phase except for the use of endometrial thinning
agents prior to the endometrial ablation procedure;
11. Able and willing to use recommended hormonal agents for the thinning of the uterine lining, unless natural cycle timing will be used for this purpose, prior to the scheduled ablation
procedure;
12. Agrees to use sponsor provided catemenial products (menstrual pads and/or tampons)
during the menstrual cycles that the PBLAC diary is used;
13. Able and willing to comply with all study tests, procedures, assessment tools and follow-
up.

1. Is pregnant as determined by urine or serum pregnancy test at screening or on day of
procedure;
2. Desires future childbearing;
3. Presence of an intrauterine device/system (IUD/IUS) that the subject is unwilling to have
removed prior to or at the time of the ablation procedure. Note: Subjects using a
hormonal releasing IUD/IUS must have their device removed prior to ablation and then
have one complete menstrual cycle at which time the baseline PBLAC diary may be
completed. An IUD/IUS may not be re-inserted following ablation. The subject must
agree to rely on either a barrier method plus spermicide, or vasectomy through the initial
12 month follow-up phase, as outlined above in inclusion (9).
4. Previous endometrial ablation procedure;
5. Evidence of an active sexually transmitted infection (STI) as determined by screening
examinations or testing as required;
Evidence of active or recurrent chronic pelvic inflammatory disease (PID) as determined
by screening examination;
7. Active infection of the genitals, vagina, cervix, uterus or urinary tract, at the time of the
procedure, as detected by screening examination and patient symptoms;
8. Presence of active endometritis identified by clinical diagnosis;
9. Presence of bacteremia, sepsis or other active systemic infection confirmed by blood
culture;
10. Suspected or confirmed gynecologic malignancy within the last five years as confirmed
by histology;
11. Endometrial hyperplasia as confirmed by histology;
12. Known clotting defects or bleeding disorders (coagulopathy), based on patient history
unless excluded by appropriate hematological examination;
13. Currently on anticoagulant therapy;
14. Hemoglobin <8gm/dl or considered by the investigator to be at risk for requiring a blood
transfusion within 12 months;
15. Prior uterine surgery (except low transverse cesarean section) which could lead to
weakening of the uterine wall (e.g. transmural myomectomy or classical cesarean
section);
16. Currently on medications that could thin the myometrial muscle such as long-term steroid
use (except inhaler or nasal therapy for asthma);
17. Severe dysmenorrhea that, in the opinion of the investigator, is secondary to
adenomyosis (AUB-A) or where adenomyosis is suspected/known by prior evaluation;
Note: Severe dysmenorrhea is defined as pain with menses that interferes with the
subject*s lifestyle and is unresponsive to over-the-counter (OTC) medications taken at the
usual dose.
18. Known uterine wall thickness of <1cm as measured by ultrasound;
19. Known bicornuate uterus;
20. Known uterine septum > 1/3 cavity length;
21. Known leiomyoma(s) that obstructs access to the uterine cavity or which prevents
distension as determined by vaginal ultrasound, SIS or hysteroscopy;
22. Known uterine and/or cervical polyps *1cm in diameter or length or which, in the opinion
of the investigator, contribute to the bleeding (AUB-P). Note: polyp removal will be
allowed during screening but subjects must complete 2 menstrual cycles and then be re-
evaluated against all inclusion and exclusion criteria prior to enrollment.
23. Known or suspected hydrosalpinx based on history or ultrasound at screening;
24. Known uterine length measurement of <6cm or >12 cm (external os to internal fundus);
25. Currently participating or planning future participation in a research study of an
investigational drug or device during the course of this investigational study;
26. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
27. An employee or relative of an employee of the Sponsor company (AEGEA Medical) or
any Investigator Site employee or relative of employee working on the study;
28. Any general health condition that, in the opinion of the Investigator, could represent an
increased risk for the subject.
29. Cannot tolerate anesthesia.