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Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding

This study has been terminated.
(Trial terminated early due to results from a similar study.)
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00496080
First received: July 3, 2007
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.


Condition Intervention
Menorrhagia
Uterine Fibroids
Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • No Surgical Re-intervention [ Time Frame: Study completion ] [ Designated as safety issue: No ]
    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.

  • Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score [ Time Frame: From baseline to 12 months ] [ Designated as safety issue: No ]
    Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.


Secondary Outcome Measures:
  • Mean Improvement in Health Related Quality of Life (HRQOL) Scores [ Time Frame: From baseline to 12 months ] [ Designated as safety issue: No ]
    Participants categorized as "better" in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. "Better" was defined as a change of +12 or more from baseline at 12 mo.

  • Maintenance of Menses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of participants with continuation of menstrual cycles without interruption for three consecutive months

  • Procedural Satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of participants with responses of either "satisfied" or "very satisfied" on a qualitative survey that ranged from "very dissatisfied" (worst) to "very satisfied" (best)

  • Decrease in Fibroid Bulk [ Time Frame: From baseline to 12-months ] [ Designated as safety issue: No ]

    Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo.

    Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200.


  • Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores [ Time Frame: From baseline to 12 months ] [ Designated as safety issue: No ]
    Number of participants categorized as "better" in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. "Better" was defined as a change of -11 or less from baseline at 12 mo.


Enrollment: 87
Study Start Date: June 2007
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DUAO Device
Doppler-guided uterine artery occlusion device (Single-arm study)
Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)
Investigational transvaginal clamp inserted one time for 6 hours.
Other Name: floSTAT

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 requirements;

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 pre-procedurally;
  • 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; · 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496080

Locations
United States, Arizona
Women's Health Research
Phoenix, Arizona, United States, 85015-2110
United States, Florida
Holy Cross Medical Group
Fort Lauderdale, Florida, United States, 33308
United States, Michigan
University Women's Care - Wayne State University
Southfield, Michigan, United States, 48034
United States, Minnesota
Minnesota Gynecology and Surgery
Edina, Minnesota, United States, 55435
United States, Missouri
St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
United States, North Carolina
North Carolina Children's & Adults' Clinical Research Foundation
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Complete Healthcare for Women
Columbus, Ohio, United States, 43231
United States, Pennsylvania
Hahnemann University Hospital - Drexel University School of Med.
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
Matlock Ob/Gyn
Arlington, Texas, United States, 76014
Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Mexico
Hospital Universitario
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Piet Hinoul, M.D. Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00496080     History of Changes
Other Study ID Numbers: 300-06-004
Study First Received: July 3, 2007
Results First Received: June 19, 2012
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health

Keywords provided by Ethicon, Inc.:
Menorrhagia associated with Uterine Fibroids

Additional relevant MeSH terms:
Leiomyoma
Menorrhagia
Myofibroma
Connective Tissue Diseases
Genital Diseases, Female
Menstruation Disturbances
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Pathologic Processes
Uterine Diseases
Uterine Hemorrhage

ClinicalTrials.gov processed this record on November 25, 2014