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

Stopped early · Not applicable

Conditions studied: Menorrhagia, Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT00496080

Run by

Ethicon, Inc.

People needed

87

Starts

2007-06-01

Expected to finish

2010-10-01

Last updated by the study team

2012-09-10

Who can join

Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Women's Health Research — Phoenix, Arizona, United States
• Holy Cross Medical Group — Fort Lauderdale, Florida, United States
• University Women's Care - Wayne State University — Southfield, Michigan, United States
• Minnesota Gynecology and Surgery — Edina, Minnesota, United States
• St. Luke's Hospital — Chesterfield, Missouri, United States
• North Carolina Children's & Adults' Clinical Research Foundation — Chapel Hill, North Carolina, United States
• Complete Healthcare for Women — Columbus, Ohio, United States
• Hahnemann University Hospital - Drexel University School of Med. — Philadelphia, Pennsylvania, United States
• Matlock Ob/Gyn — Arlington, Texas, United States
• St. Joseph's Health Care — London, Ontario, Canada
• Hospital Universitario — Monterrey, Nuevo León, Mexico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.