Uterine Artery Occlusion for Fibroid Related Bleeding

Uterine Fibroids Clinical Trial

Official title:

An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00496067
• Other study ID #: 300-06-008
• Status: Terminated
• Phase: N/A
• First received: July 3, 2007
• Last updated: March 8, 2011
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: German Institute of Medical Documentation and InformationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Switzerland: SwissmedicNorway: Directorate of HealthDenmark: Danish Medicines AgencyNetherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Description:

DUAO is intended for bilateral occlusion of the uterine arteries

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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);

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Menorrhagia
• Uterine Fibroids

Intervention

Device:
• Doppler-Guided Uterine Artery Occlusion Device
For bilateral occlusion of the uterine arteries

Locations

Country	Name	City	State
Denmark	Viborg County Hospital	Viborg
France	University Hospital	Angers cedex
France	Service de Gynecologie Obsterique, Hopital Antoine Beclere	Clamart Cedex
France	Maternite les Bazennes	Dunkerque
France	CHRU de Lille, Hopital Jeanne de Flandre	Lille Cedex
Germany	Universitaeklinikum Erlangen	Erlangen
Germany	Universitats-Frauenklinik Tubingen	Tubingen
Netherlands	VU Medical Center	Amsterdam
Norway	Ullevaal University	Oslo
Switzerland	Universitats-Frauenklinik	Bern
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lack of surgical re-intervention		Post-op through end of study	No
Secondary	Percentage of subjects with improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity and Health Related Quality of Life (HRQL) scores.		6, 12 and 24 months	No
Secondary	Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores.		6, 12 and 24 months	No
Secondary	Mean HRQL subscales.		6, 12 and 24 months	No
Secondary	Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score.		6 and 12 months	No
Secondary	Mean change in PBLAC scores.		Baseline to 6 and 12 months	No
Secondary	Percentage of subjects with decrease in fibroid load based on independent MRI review.		6 months	No
Secondary	Percentage of subjects with maintenance of menses as defined by continuation of menstrual cycles without an interruption of three consecutive months		12 months	No
Secondary	Percentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied.		12 months	No
Secondary	Lack of surgical re-intervention.		24 months	No
Secondary	Pain score		Discharge or 24-hour post clamp removal, whichever is earlier	No
Secondary	Days to normal activities (household, work and sexual intercourse)		Post procedure	No
Secondary	Euro-QOL expressed as change from baseline for each of the 6 domains and Visual Analogue Scale (VAS)		1, 3, 6 and 12 months	No
Secondary	Nights in hospital		Total and post procedure	No