Uterine Artery Occlusion for Fibroid Related Bleeding

NCT00496067 | Terminated DMC

• 1 other identifier: 300-06-008
• Study Type: interventional
• Target: 91
• Locations: 7 countries
• Sites: 14

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.

Conditions

Menorrhagia; Uterine Fibroids

Keywords

Fibroids; Menorrhagia; Menorrhagia associated with uterine fibroids

Outcome Measures

Primary Outcomes (1)

• Lack of surgical re-intervention

  Post-op through end of study

Secondary Outcomes (13)

• 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

• Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores.

  6, 12 and 24 months

• Mean HRQL subscales.

  6, 12 and 24 months

• Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score.

  6 and 12 months

• Mean change in PBLAC scores.

  Baseline to 6 and 12 months

Study Arms (1)

1

EXPERIMENTAL

DUAO Device

Device: Doppler-Guided Uterine Artery Occlusion Device

Interventions

Doppler-Guided Uterine Artery Occlusion Device DEVICE

For bilateral occlusion of the uterine arteries

Also known as: floSTAT

1

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (14)

Viborg County Hospital

Viborg, DK-8800, Denmark

Location

University Hospital

Angers, 49033, France

Location

Service de Gynecologie Obsterique, Hopital Antoine Beclere

Clamart, 92414, France

Location

Maternite les Bazennes

Dunkirk, 59430, France

Location

CHRU de Lille, Hopital Jeanne de Flandre

Lille, 59037, France

Location

Universitaeklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitats-Frauenklinik Tubingen

Tübingen, 72076, Germany

Location

VU Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Ullevaal University

Oslo, N-0407, Norway

Location

Universitats-Frauenklinik

Bern, 3012, Switzerland

Location

M1 Maternity, Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Hull and East Yorkshire Women & Children Hospital

Hull, HU3 2JZ, United Kingdom

Location

Elizabeth Garret Anderson Hospital

London, WC1E 6DH, United Kingdom

Location

Queen Elizabeth the Queen Mother Hospital

Margate, CT9 4AN, United Kingdom

Location

MeSH Terms

Conditions

Menorrhagia; Leiomyoma

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• David Robinson, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 9, 2011

Record last verified: 2011-03

Locations

NL (1); NO (1); DE (2); FR (4); DK (1); CH (1); GB (4)