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

A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated 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.

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.