a pilot study to determine optimal procedure steps to obtain and maintain uterine artery occlusion with the d-uao device

Conditions: Uterine Fibroids

Summary: 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.

Eligibility criteria:
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.