Uterine Artery Occlusion for Fibroid Related Bleeding

NCT ID: NCT00496067

Last Updated: 2011-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-12-31

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.

Detailed Description

DUAO is intended for bilateral occlusion of the uterine arteries

Conditions

Menorrhagia; Uterine Fibroids

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

DUAO Device

Group Type: EXPERIMENTAL

Doppler-Guided Uterine Artery Occlusion Device

Intervention Type: DEVICE

For bilateral occlusion of the uterine arteries

Interventions

Doppler-Guided Uterine Artery Occlusion Device

For bilateral occlusion of the uterine arteries

Intervention Type: DEVICE

Other Intervention Names

floSTAT

Eligibility 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);

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Ethicon Inc.

Principal Investigators

David Robinson, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

Viborg County Hospital

Viborg, , Denmark

University Hospital

Angers, , France

Service de Gynecologie Obsterique, Hopital Antoine Beclere

Clamart, , France

Maternite les Bazennes

Dunkirk, , France

CHRU de Lille, Hopital Jeanne de Flandre

Lille, , France

Universitaeklinikum Erlangen

Erlangen, , Germany

Universitats-Frauenklinik Tubingen

Tübingen, , Germany

VU Medical Center

Amsterdam, , Netherlands

Ullevaal University

Oslo, , Norway

Universitats-Frauenklinik

Bern, , Switzerland

M1 Maternity, Bradford Royal Infirmary

Bradford, , United Kingdom

Hull and East Yorkshire Women & Children Hospital

Hull, , United Kingdom

Elizabeth Garret Anderson Hospital

London, , United Kingdom

Queen Elizabeth the Queen Mother Hospital

Margate, , United Kingdom

Countries

Denmark; France; Germany; Netherlands; Norway; Switzerland; United Kingdom

Other Identifiers

300-06-008

Identifier Type: -

Identifier Source: org_study_id