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Uterine Artery Occlusion for Fibroid Related Bleeding
This study is currently recruiting participants.
Verified by Ethicon, Inc., March 2009
First Received: July 3, 2007   Last Updated: March 16, 2009   History of Changes
Sponsored by: Ethicon, Inc.
Information provided by: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00496067
  Purpose

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 Intervention
Menorrhagia
Uterine Fibroids
Device: Doppler-Guided Uterine Artery Occlusion Device

MedlinePlus related topics: Menstruation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Lack of surgical re-intervention [ Time Frame: Post-op through end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores. [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Mean HRQL subscales. [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Mean change in PBLAC scores. [ Time Frame: Baseline to 6 and 12 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with decrease in fibroid load based on independent MRI review. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Lack of surgical re-intervention. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Pain score [ Time Frame: Discharge or 24-hour post clamp removal, whichever is earlier ] [ Designated as safety issue: No ]
  • Days to normal activities (household, work and sexual intercourse) [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Nights in hospital [ Time Frame: Total and post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
DUAO Device
Device: Doppler-Guided Uterine Artery Occlusion Device
For bilateral occlusion of the uterine arteries

Detailed Description:

DUAO is intended for bilateral occlusion of the uterine arteries

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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);
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496067

Contacts
Contact: Judi Gauld, BSc (Hons) +44 150 659 4679 jgauld@its.jnj.com

Locations
Denmark
Viborg County Hospital Recruiting
Viborg, Denmark, DK-8800
France
Service de Gynecologie Obsterique, Hopital Antoine Beclere Recruiting
Clamart Cedex, France, 92414
University Hospital Recruiting
Angers cedex, France, 49033
Maternite les Bazennes Recruiting
Dunkerque, France, 59430
Hopital Nord Withdrawn
Marseille Cedex 15, France, 13015
CHRU de Lille, Hopital Jeanne de Flandre Recruiting
Lille Cedex, France, 59037
Principal Investigator: Jean-Philippe Lucot, MD            
Germany
Universitaeklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Universitats-Frauenklinik Tubingen Recruiting
Tubingen, Germany, 72076
Netherlands
VU Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Norway
Ullevaal University Recruiting
Oslo, Norway, N-0407
Switzerland
Universitats-Frauenklinik Recruiting
Bern, Switzerland, 3012
United Kingdom
Hull and East Yorkshire Women & Children Hospital Recruiting
Hull, United Kingdom, HU3 2JZ
Principal Investigator: Steve Killick, MD            
Elizabeth Garret Anderson Hospital Not yet recruiting
London, United Kingdom, WC1E 6DH
M1 Maternity, Bradford Royal Infirmary Recruiting
Bradford, United Kingdom, BD9 6RJ
Queen Elizabeth the Queen Mother Hospital Recruiting
Margate, United Kingdom, CT9 4AN
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: David Robinson, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Ethicon Inc. ( Judi Gauld, Manager Clinical Research )
Study ID Numbers: 300-06-008
Study First Received: July 3, 2007
Last Updated: March 16, 2009
ClinicalTrials.gov Identifier: NCT00496067     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Germany: German Institute of Medical Documentation and Information;   France: Afssaps - French Health Products Safety Agency;   Switzerland: Swissmedic;   Norway: Directorate for Health and Social Affairs;   Denmark: Danish Medicines Agency;   Netherlands: Dutch Health Care Inspectorate

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

Study placed in the following topic categories:
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Myofibroma
Menstruation Disturbances
Uterine Hemorrhage
Connective Tissue Diseases
Uterine Diseases
Menorrhagia
Hemorrhage
Leiomyoma

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

ClinicalTrials.gov processed this record on May 07, 2009