Uterine Artery Occlusion for Fibroid Related Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496067
Recruitment Status : Terminated (Data required further pilot work to be undertaken.)
First Posted : July 4, 2007
Last Update Posted : March 9, 2011
Information provided by:
Ethicon, Inc.

Brief Summary:
The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.

Condition or disease Intervention/treatment Phase
Menorrhagia Uterine Fibroids Device: Doppler-Guided Uterine Artery Occlusion Device Not Applicable

Detailed Description:
DUAO is intended for bilateral occlusion of the uterine arteries

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding
Study Start Date : April 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: 1
DUAO Device
Device: Doppler-Guided Uterine Artery Occlusion Device
For bilateral occlusion of the uterine arteries
Other Name: floSTAT

Primary Outcome Measures :
  1. Lack of surgical re-intervention [ Time Frame: Post-op through end of study ]

Secondary Outcome Measures :
  1. Percentage of subjects with improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity and Health Related Quality of Life (HRQL) scores. [ Time Frame: 6, 12 and 24 months ]
  2. Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores. [ Time Frame: 6, 12 and 24 months ]
  3. Mean HRQL subscales. [ Time Frame: 6, 12 and 24 months ]
  4. Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score. [ Time Frame: 6 and 12 months ]
  5. Mean change in PBLAC scores. [ Time Frame: Baseline to 6 and 12 months ]
  6. Percentage of subjects with decrease in fibroid load based on independent MRI review. [ Time Frame: 6 months ]
  7. Percentage of subjects with maintenance of menses as defined by continuation of menstrual cycles without an interruption of three consecutive months [ Time Frame: 12 months ]
  8. Percentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied. [ Time Frame: 12 months ]
  9. Lack of surgical re-intervention. [ Time Frame: 24 months ]
  10. Pain score [ Time Frame: Discharge or 24-hour post clamp removal, whichever is earlier ]
  11. Days to normal activities (household, work and sexual intercourse) [ Time Frame: Post procedure ]
  12. Euro-QOL expressed as change from baseline for each of the 6 domains and Visual Analogue Scale (VAS) [ Time Frame: 1, 3, 6 and 12 months ]
  13. Nights in hospital [ Time Frame: Total and post procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 25 to 50 years of age
  • Subject has a negative urine or blood pregnancy test prior to the procedure. At the time of enrollment to the study, the subject has no intent of further childbearing and intends to use appropriate contraception throughout the first 12 months of the study period (unless sterilized)
  • Normal pap smear within 36 months of study procedure (most recent)
  • Cervix suitable for tenaculum placement as determined by pelvic exam (adequate length of cervix, absence of cervical fibroid/lower fibroid to prevent clamp placement)
  • At least one intra-mural or sub-serosal or sub-mucosal uterine fibroid with a minimum diameter of greater than or equal to 3 cm, and all fibroids with a diameter less than or equal to 8cm with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound
  • Symptomatic subject presenting with at least one of the following fibroid symptoms: pelvic pressure, menorrhagia, metrorrhagia, pelvic pain, increasing abdominal girth or dyspareunia due to fibroids.
  • Subject has evidence of bilateral ureteric flow
  • Subject agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Ethics Committee-approved informed consent.

Exclusion Criteria:

  • Pregnancy as confirmed by positive urine or blood pregnancy test
  • Menopausal as defined by elevated follicle-stimulating hormone (FSH) and decreased oestradiol hormone levels as determined by the hospital local laboratory reference range criteria
  • Presence of any pedunculated sub-mucosal or pedunculated sub-serosal fibroid(s) as determined by MRI, ultrasound or hysteroscopy
  • Presence of an intra-uterine device (IUD)
  • Any hydronephrosis as determined on renal ultrasound prior to the procedure
  • Clinical history of any thrombo-embolic disease or known thrombophilia
  • Blood Urine Nitrogen (BUN) greater than 7.2mmol/L* and/or serum creatinine greater than 106μmol/L* unresolved with change in diet or hydration
  • History or current evidence of gynecologic malignancy (confirmed by hysteroscopy or endometrial biopsy), atypical endometrial hyperplasia, or chronic pelvic inflammatory disease
  • Pelvic mass outside the uterus other than uterine fibroids
  • Any current acute or chronic systemic infection or localized pelvic infection, including a urinary tract infection
  • Use of Gonadotropin-Releasing Hormone (GnRH) agonist, danozol or mifepristone within 6-months prior to the start of the study procedure
  • Using anticoagulation therapy (except over the counter treatments (e.g. aspirin)), or have an underlying bleeding disorder
  • Unsuitable for MRI examination (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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00496067

Viborg County Hospital
Viborg, Denmark, DK-8800
University Hospital
Angers cedex, France, 49033
Service de Gynecologie Obsterique, Hopital Antoine Beclere
Clamart Cedex, France, 92414
Maternite les Bazennes
Dunkerque, France, 59430
CHRU de Lille, Hopital Jeanne de Flandre
Lille Cedex, France, 59037
Universitaeklinikum Erlangen
Erlangen, Germany, 91054
Universitats-Frauenklinik Tubingen
Tubingen, Germany, 72076
VU Medical Center
Amsterdam, Netherlands, 1081 HV
Ullevaal University
Oslo, Norway, N-0407
Bern, Switzerland, 3012
United Kingdom
M1 Maternity, Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
Hull and East Yorkshire Women & Children Hospital
Hull, United Kingdom, HU3 2JZ
Elizabeth Garret Anderson Hospital
London, United Kingdom, WC1E 6DH
Queen Elizabeth the Queen Mother Hospital
Margate, United Kingdom, CT9 4AN
Sponsors and Collaborators
Ethicon, Inc.
Study Director: David Robinson, MD Ethicon, Inc.

Responsible Party: Judi Gauld, Manager Clinical Research, Ethicon Inc. Identifier: NCT00496067     History of Changes
Other Study ID Numbers: 300-06-008
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: March 9, 2011
Last Verified: March 2011

Keywords provided by Ethicon, Inc.:
Menorrhagia associated with uterine fibroids

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes