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

Not Applicable

Terminated

• Conditions: Uterine Fibroids; Menorrhagia
• Interventions: Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)

• Registration Number: NCT00496080
• Lead Sponsor: Ethicon, Inc.

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Results First Submitted: 2012-06-19
• Results First Submitted QC: 2012-06-19
• Results First Posted: 2012-07-24
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DUAO Device	Doppler-Guided Uterine Artery Occlusion Device (DUAO)	Doppler-guided uterine artery occlusion device (Single-arm study)

Primary Outcome Measures

Name	Time	Method
No Surgical Re-intervention	Study completion	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	From baseline to 12 months	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

Name	Time	Method
Maintenance of Menses	12 months	Number of participants with continuation of menstrual cycles without interruption for three consecutive months
Decrease in Fibroid Bulk	From baseline to 12-months	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 Health Related Quality of Life (HRQOL) Scores	From baseline to 12 months	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.
Procedural Satisfaction	12 months	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)
Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores	From baseline to 12 months	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.

Trial Locations

Locations (11)

Women's Health Research; 🇺🇸 Phoenix, Arizona, United States

Holy Cross Medical Group; 🇺🇸 Fort Lauderdale, Florida, United States

University Women's Care - Wayne State University; 🇺🇸 Southfield, Michigan, United States

Minnesota Gynecology and Surgery; 🇺🇸 Edina, Minnesota, United States

St. Luke's Hospital; 🇺🇸 Chesterfield, Missouri, United States

North Carolina Children's & Adults' Clinical Research Foundation; 🇺🇸 Chapel Hill, North Carolina, United States

Complete Healthcare for Women; 🇺🇸 Columbus, Ohio, United States

Hahnemann University Hospital - Drexel University School of Med.; 🇺🇸 Philadelphia, Pennsylvania, United States

Matlock Ob/Gyn; 🇺🇸 Arlington, Texas, United States

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada

Hospital Universitario; 🇲🇽 Monterrey, Nuevo Leon, Mexico