Uterine Artery Occlusion for Fibroid Related Bleeding

This study has been terminated.
(Data required further pilot work to be undertaken.)
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00496067
First received: July 3, 2007
Last updated: March 8, 2011
Last verified: March 2011
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 91
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DUAO Device
Device: Doppler-Guided Uterine Artery Occlusion Device
For bilateral occlusion of the uterine arteries
Other Name: floSTAT

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496067

Locations
Denmark
Viborg County Hospital
Viborg, Denmark, DK-8800
France
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
Germany
Universitaeklinikum Erlangen
Erlangen, Germany, 91054
Universitats-Frauenklinik Tubingen
Tubingen, Germany, 72076
Netherlands
VU Medical Center
Amsterdam, Netherlands, 1081 HV
Norway
Ullevaal University
Oslo, Norway, N-0407
Switzerland
Universitats-Frauenklinik
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.
Investigators
Study Director: David Robinson, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Judi Gauld, Manager Clinical Research, Ethicon Inc.
ClinicalTrials.gov Identifier: NCT00496067     History of Changes
Other Study ID Numbers: 300-06-008
Study First Received: July 3, 2007
Last Updated: March 8, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: German Institute of Medical Documentation and Information
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Switzerland: Swissmedic
Norway: Directorate of Health
Denmark: Danish Medicines Agency
Netherlands: Dutch Health Care Inspectorate

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

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

ClinicalTrials.gov processed this record on July 23, 2014