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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Menorrhagia, Uterine Fibroids

Intervention / Treatment
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* Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DUAO Device<br>Doppler-guided uterine artery occlusion device (Single-arm study) | Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)<br>* Investigational transvaginal clamp inserted one time for 6 hours.<br>* Other names: floSTAT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No Surgical Re-intervention | 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. | Study completion | 
| Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score | 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. | From baseline to 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menorrhagia associated with Uterine Fibroids