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
- 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
- Confirmation of the ability to clearly visualise bilateral uterine arteries with
- 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
- Prior endometrial ablation, uterine artery embolization, or uterine artery ligation.
- Pregnancy (As confirmed by a urine pregnancy test at screening and immediately prior
- 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
- 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.