A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device

A Pilot Study to Determine the Optimal Procedure Steps to Obtain and Maintain Bilateral Uterine Artery Occlusion Using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device in Women With Uterine Fibroids

This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.

1. Group 1 - beginning with the use of the current instructions for use (IFU) will have adjustments made as necessary to the D-UAO procedural steps for uterine artery occlusion confirmed by 2/3-D Power Colour Doppler ultrasound (2/3DPD).
2. Group 2 - verify that optimal D-UAO IFU procedural steps generated in Group 1 as confirmed by 2/3DPD.
3. Group 3 - verify that the optimal D-UAO procedural steps are reproducible in the hands of multiple surgeons in addition to the group 1 investigators, as confirmed by 2/3DPD.

Inclusion Criteria:

• Age 25-55 years with regular menses and at least one symptom related to uterine fibroids (for example heavy bleeding).
• Completed child-bearing.
• 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 abdominal/transvaginal ultrasound.
• Confirmation of the ability to clearly visualise bilateral uterine arteries with 2/3DPD.
• Dominant fibroid (defined as >3cm in diameter) must be well vascularised as determined by CE-MRI (for Group 2 and 3 patients only).
• Able to tolerate the required prolonged supine position during treatment (approximately 6 hours).
• Cervix suitable for tenaculum placement as determined by pelvic exam.
• Normal Pap smear within the last 36 months.
• Agrees to participate in the study, and following review of the patient information sheet documents this agreement by signing the Ethics Committee approved informed consent.

Exclusion Criteria:

• Prior endometrial ablation, uterine artery embolization, or uterine artery ligation.
• Pregnancy (As confirmed by a urine pregnancy test at screening and immediately prior to procedure).
• One or more lower uterine segment fibroids determined through pelvic exam which in the examiner's opinion would prevent proper clamp application.
• Any known contraindications to the contrast agent to be used for the CE-MRI as determined by the study radiologist (for Group 2 and 3 patients only).
• Pelvic mass outside the uterus suggesting other disease processes.
• An intrauterine device (IUD) in place during the day of procedure.
• Hydronephrosis as determined by interpretation of a pre-procedure renal ultrasound.
• No ureteral jets observed on ultrasound prior to clamping.
• Presence of a pedunculated fibroid determined by ultrasound, hysteroscopy, or saline infused sonography or CE MRI.
• Any current acute or chronic systemic infection or localized pelvic infection, including an unresolved urinary tract infection.
• Clinical history of any thromboembolic disease.
• History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic inflammatory disease.
• Using anticoagulation therapy (except OTC treatments, e.g. aspirin), or has a known underlying bleeding disorder.
• In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.