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A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding

25 Years
50 Years
Not Enrolling
Menorrhagia, Uterine Fibroids

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Trial Information

A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding

The GYNECARE GYNOCCLUDE D-UAO Instruments are single-use disposable instruments consisting
of a GYNECARE GYNOCCLUDE Uterine Stabilizer, a GYNECARE GYNOCCLUDEM Introducer Sheath, a

Inclusion Criteria:

- 25 to 50 years of age;

- PBLAC score of 150 or greater;

- Completed child-bearing;

- Normal Pap smear within 12 months;

- Cervix suitable for tenaculum placement as determined by pelvic exam;

- At least one uterine fibroid of 3 cm diameter or greater with a prevailing pathology
(e.g., as opposed to adenomyosis) of fibroids determined through ultrasound;

- Willing to maintain use or non-use of hormonal contraception from 3 months pre-study
throughout the 12-month follow-up period;

- Willing to maintain use or non-use of anti-fibrinolytic agents from 3 months
pre-study throughout the 12-month follow-up period;

- Able to tolerate the required prolonged supine position during treatment
(approximately 6 hours);

- Willing and able to provide informed consent and to follow study-related

Exclusion Criteria:

- Pregnancy (as confirmed immediately prior to procedure)

- Fibroid diameter greater than 8.0 cm determined through transvaginal ultrasound; [or
if 2 dimensions are measured, total dimension greater than 16 cm; or if the 3
dimensions (length, height, width) are measured, total dimension greater than 24 cm];

- Presence of a pedunculated fibroid determined by ultrasound; hysteroscopy, or saline
infused sonography;

- Hydronephrosis as determined by radiologist interpretation on renal ultrasound

- Menopausal;

- Clinical history of any thromboembolic disease;

- Blood urine nitrogen (BUN) greater than 20 mg/dL and/or serum creatinine greater than
1.2 mg/dL unresolved with change in diet or hydration; ยท One or more lower uterine
segment fibroids determined through pelvic exam;

- History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic
inflammatory disease;

- Abnormal endometrial biopsy within the last 6 months prior to procedure;

- Pelvic mass outside the uterus suggesting other disease processes;

- Any current acute or chronic systemic infection or localized pelvic infection,
including an unresolved urinary tract infection;

- Using GnRH agonist or mifepristone within 6-months prior to the start of the study;

- An intrauterine device (IUD) in place;

- Using anticoagulation therapy (except OTC treatments (e.g. aspirin)), or have an
underlying bleeding disorder;

- Unsuitable for MRI examination, if within study subgroup to undergo MRI evaluation
(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);

- Grade 1 for 3D Color Doppler or no flow observed for cystoscopy on ureter flow
assessment if applicable.

Type of Study:


Study Design:

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

Outcome Measure:

No Surgical Re-intervention

Outcome Description:

Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.

Outcome Time Frame:

Study completion

Safety Issue:


Principal Investigator

Piet Hinoul, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ethicon, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

October 2010

Related Keywords:

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



St. Luke's Hospital Kansas City, Missouri  64111
Women's Health Research Phoenix, Arizona  85015
Holy Cross Medical Group Fort Lauderdale, Florida  33308
University Women's Care - Wayne State University Southfield, Michigan  48034
Minnesota Gynecology and Surgery Edina, Minnesota  55435
North Carolina Children's & Adults' Clinical Research Foundation Chapel Hill, North Carolina  27514
Complete Healthcare for Women Columbus, Ohio  43231
Hahnemann University Hospital - Drexel University School of Med. Philadelphia, Pennsylvania  19102
Matlock Ob/Gyn Arlington, Texas  76014