Ablation system to treat abnormal uterine bleeding in women with prior cesarean delivery

Inclusion Criteria:

1. Signed participant informed consent form (ICF).
2. Females aged ≥ 30 years and ≤ 55 years at baseline with no desire to conceive, with or without simple endometrial hyperplasia (without atypia) and with a history of cesarean section.
3. Diagnosis of AUB.
4. Documented premenopausal status (follicle-stimulating hormone (FSH) level ≤ 40 mIU/mL), women who don't want to receive hormonal treatment or who have failed to respond to hormonal treatment.
5. Pictorial Blood Loss Assessment Chart (PBAC) score ≥150 at baseline.
6. Normal endometrial biopsy.
7. Negative PAP test.
8. Willingness to follow all study procedures, including attending all site visits, tests, and examinations.
9. Willingness to avoid the use of vaginal ring, hormonal intrauterine device (concomitant IUD such as Essure is not allowed prior to the ATTTVAS Ablation Treatment), oral contraceptives during the study period.

Exclusion Criteria:

1. BMI ≥40
2. Postmenopausal status.
3. Undiagnosed vaginal bleeding.
4. Cesarean scar defect which in the opinion of the Investigator is contraindicating endometrial ablation.
5. A participant with a history of a prior completed endometrial ablation procedure and/or endometrial resection including endometrial ablation/resection performed immediately (between the screening visit and the EA procedure) prior to the ATTTVAS ablation treatment regardless of the modality by which it was performed.
6. Uterine cavity-length is \<4 and \>6.4 cm (without cervix length).
7. Pregnant or breastfeeding.
8. Less than 1-year post-partum.
9. Any contraindication to endometrial ablation.
10. History of abortion (including spontaneous/incomplete) within 8 weeks before the study treatment (6 weeks is acceptable if transvaginal ultrasound confirms uterus normalization).
11. History of previous transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior (between the screening visit and the EA procedure) to the ATTTVAS ablation treatment.
12. Documented or suspected pelvic inflammatory disease, active/acute endometritis, sexually transmitted disease, bacteremia, sepsis, other active local and/or systemic infections.
13. Documented active genital or urinary tract infection (e.g., cervicitis, vaginitis, endometritis, salpingitis or cystitis) at the time of treatment.
14. Congenital malformations of the female genital tract or of the uterus, fibroid(s) distorting the uterine cavity, or large (\> 1 cm) endometrial polyp(s).
15. Subjects with suspected or known coagulopathies or currently receiving anticoagulation therapy.
16. Participants currently on medications that could thin the myometrial muscle, such as long-term steroid use (except for inhaler or nasal therapy for asthma).
17. Documented cervical dysplasia, complex or atypical endometrial hyperplasia, abdominal or pelvic cancer.
18. Presence of any relevant severe organic, systemic, or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that in the opinion of the Investigator may interfere with the participation to the study.
19. Active malignant neoplasm of any type, or history of malignancies (participants with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are acceptable).
20. Participation in another investigational study within 30 days before the study treatment.
21. Recent history (past 6 months) or suspicion of alcohol abuse or drug addiction.
22. Inability to follow study procedures.
23. History of allergic reactions to any components used in the sedation protocol at the site.

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