Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding

Inclusion Criteria: * 25 to 50 years of age; * PBLAC score of 150 or greater; * Completed child-bearing; * Normal Pap smear within 12 months; * Cervix suitable for tenaculum placement as determined by pelvic exam; * At least one uterine fibroid of 3 cm diameter or greater with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound; * Willing to maintain use or non-use of hormonal contraception from 3 months pre-study throughout the 12-month follow-up period; * Willing to maintain use or non-use of anti-fibrinolytic agents from 3 months pre-study throughout the 12-month follow-up period; * Able to tolerate the required prolonged supine position during treatment (approximately 6 hours); * Willing and able to provide informed consent and to follow study-related requirements; Exclusion Criteria: * Pregnancy (as confirmed immediately prior to procedure) * Fibroid diameter greater than 8.0 cm determined through transvaginal ultrasound; \[or if 2 dimensions are measured, total dimension greater than 16 cm; or if the 3 dimensions (length, height, width) are measured, total dimension greater than 24 cm\]; * Presence of a pedunculated fibroid determined by ultrasound; hysteroscopy, or saline infused sonography; * Hydronephrosis as determined by radiologist interpretation on renal ultrasound pre-procedurally; * Menopausal; * Clinical history of any thromboembolic disease; * Blood urine nitrogen (BUN) greater than 20 mg/dL and/or serum creatinine greater than 1.2 mg/dL unresolved with change in diet or hydration; · One or more lower uterine segment fibroids determined through pelvic exam; * History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic inflammatory disease; * Abnormal endometrial biopsy within the last 6 months prior to procedure; * Pelvic mass outside the uterus suggesting other disease processes; * Any current acute or chronic systemic infection or localized pelvic infection, including an unresolved urinary tract infection; * Using GnRH agonist or mifepristone within 6-months prior to the start of the study; * An intrauterine device (IUD) in place; * Using anticoagulation therapy (except OTC treatments (e.g. aspirin)), or have an underlying bleeding disorder; * Unsuitable for MRI examination, if within study subgroup to undergo MRI evaluation (e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices); * Prior endometrial ablation, uterine artery embolization, or uterine artery ligation; * Poor procedural candidate due to medical conditions as determined by the investigator (e.g. anesthesia class, renal insufficiency, heart disease); * Grade 1 for 3D Color Doppler or no flow observed for cystoscopy on ureter flow assessment if applicable.