doppler-guided uterine artery occlusion (duao) device for fibroid related bleeding

Conditions: Menorrhagia; Uterine Fibroids

Summary: 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.

Keywords: menorrhagia associated with uterine fibroids