IUB SEAD RED (Revolutionary Endometrial Ablation Device Study)

Exclusion Criteria

• •1. Pregnant women or those who desire to conceive at any time in the future
• •2. An endometrial cavity with any of the following: congenital malformation of (eg septate uterus), endometrial polyp \>8 mm in largest dimension, FIGO Type 0 or 1 leiomyomas of any diameter or Type 2 leiomyomas \> 3 cm in mean diameter; intrauterine adhesions/ synechiae that distort the endometrial cavity sufficient to impair deployment of the SEAD device.
• •3. Underwent prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural abdominal (laparoscopic or laparotomic) or hysteroscopic myomectomy and/or metroplasty during last 3 months prior to screening, classical Cesarean section, or endometrial ablation
• •4. Have an abnormal endometrial biopsy that suggests either anovulation or a risk for the development of endometrial cancer (i.e., benign hyperplasia, endometrial hyperplasia with atypia, endometrial intraepithelial neoplasia, endometrial cancer)
• •5. Have a documented clinical history of titanium allergy or hypersensitivity to any component of IUB™SEAD™.
• •6. Suffers from active endometritis, active pelvic inflammatory disease (PID) or active sexually transmitted disease (STD)
• •7. Suffers from active infection of the genitals, vagina, cervix, or uterus
• •8. Presence of bacteremia, sepsis, or other active systemic infection
• •9. Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
• •10. Known clotting defects or bleeding disorders
• •11. Currently using anticoagulant treatment
• •12. 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.
• •13. Suffers from clinically significant adenomyosis indicated by subject complaints or imaging
• •14. Presence of an implantable contraceptive device, unless subject agrees to have the device removed immediately on screening, and prior to PBLAC assessment
• •15. Post-partum ≤ 6-months
• •16. 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
• •17. 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.
• •18. Has a polyp that was not removed before day of treatment