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

The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.

The GYNECARE GYNOCCLUDE D-UAO Instruments are single-use disposable instruments consisting of a GYNECARE GYNOCCLUDE Uterine Stabilizer, a GYNECARE GYNOCCLUDEM Introducer Sheath, a GYNECARE GYNOCCLUDE Doppler Clamp, and a GYNECARE GYNOCCLUDE Coupler.

Eligibility Criteria:
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.