Study to Assess the Safety and Efficacy of the IUB SEAD™ Device (AUB)

This is an interventional treatment trial for Abnormal Uterine Bleeding Read More

Inclusion Criteria:

1. Female subject age 35 to 50 years, inclusive
2. Suffering from heavy menstrual bleeding with no definable organic cause and are candidates for global endometrial ablation or surgical treatment
3. Have a histological finding in a recent (max 4-month-old, with a window of 1 month) endometrial biopsy (Pipelle® or other non-treatment-based biopsy) that demonstrates benign endometrial histology: proliferative endometrium and/or disordered endometrium and/or histological findings associated with dysfunctional endometrium (e.g. irregular shading, un-ovulatory bleeding and such); no histological findings of hyperplasia are allowed
4. Premenopausal status confirmed by FSH level measurement at screening (FSH < 40 IU/L). FSH level measurement will be repeated in case of a borderline result
5. Screening hemoglobin levels >9.0 g/dL
6. Uterine sound measurement of 6.5-11 cm (external os to internal fundus)
7. PBAC score of >150 for 3 months prior to study treatment or PBAC score >150 one month prior to study treatment for women who had at least 3 prior months (documented) of failed medical therapy
8. Predictable, cyclic menstrual cycles
9. Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment

10. Sexually active women must agree to use an effective method of contraception throughout the course of the study. For this study, effective methods of contraception are considered to be those listed below:

    • Barrier method, i.e., (a) condom (male or female) with spermicide or (b) diaphragm with spermicide or
    • Vasectomy (partner), or
    • Abstinence, if in line with the preferred and usual lifestyle of the subject [where abstinence is defined as refraining from heterosexual intercourse]
11. Subject able to understand and sign a written informed consent form
12. Subject willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
13. Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram

Exclusion Criteria:

1. Pregnant women or those who desire to conceive at any time in the future
2. Congenital malformation of the uterine cavity (bicornuate, septate)
3. Inability to visualize the uterine cavity because of intracavitary pathology and/or significant uterine asymmetry, including patients with submucous myomas and/or polyps and synechiae that heavily distort the uterine cavity
4. Underwent prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy, classical Cesarean section, endometrial ablation, hysteroscopic resection) or a uterine biopsy accompanied by curettage in the last 12 months
5. Have abnormal endometrial biopsy (i.e., unresolved adenomatous complex hyperplasia, endometrial cancer)
6. Have a documented clinical history of metal allergy or hypersensitivity
7. Suffers from active endometritis, active pelvic inflammatory disease (PID) or active sexually transmitted disease (STD)
8. Suffers from active infection of the genitals, vagina, cervix, or uterus
9. Presence of bacteremia, sepsis, or other active systemic infection
10. Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
11. Known clotting defects or bleeding disorders or subjects who went through blood transfusion (for any reason) in the three months prior enrollment
12. Currently using anticoagulant treatment
13. Subjects with abnormal Papanicolaou (Pap) test or atypical squamous cells of undetermined significance (ASCUS) with positive high-risk human papilloma virus (HPV) test result within the appropriate screen timeframe, and prior to SEAD™ treatment. Alternatively, a colposcopy performed prior to SEAD™ treatment, that showed evidence of dysplasia requiring treatment. In case treatment was performed > 6 months prior to enrollment and follow-up was done with no evidence of disease by clinical evaluation, the subject is eligible.
14. Previously had endometrial ablation procedure of any kind
15. Suffers from clinically significant adenomyosis indicated by subject complaints, imaging or clinician's judgment
16. Presence of an implantable contraceptive device
17. Post-partum ≤ 6-months
18. Currently participating in or considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study
19. Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could present an increased risk for the subject or impact the subject's ability to comply with protocol requirements.