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

25 Years
50 Years
Not Enrolling
Menorrhagia, Uterine Fibroids

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Trial Information

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

DUAO is intended for bilateral occlusion of the uterine arteries

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

- 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);

Type of Study:


Study Design:

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

Outcome Measure:

Lack of surgical re-intervention

Outcome Time Frame:

Post-op through end of study

Safety Issue:


Principal Investigator

David Robinson, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ethicon, Inc.


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

April 2007

Completion Date:

December 2009

Related Keywords:

  • Menorrhagia
  • Uterine Fibroids
  • Fibroids
  • Menorrhagia
  • Menorrhagia associated with uterine fibroids
  • Hemorrhage
  • Leiomyoma
  • Myofibroma
  • Menorrhagia