Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study

Study Overview
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Brief Summary
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The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.

Official Title
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Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores

Conditions
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Leiomyoma, Uterine Fibroids, Menorrhagia

Intervention / Treatment
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* Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-menopausal Regular, consistent menstrual cycles Serum progesterone > 6 ng/ml (19 nmol/L) 2 months history of PBLAC score of 150-500 Maximum of 4 type I, type II, or intramural fibroids Patient is at low risk for cervical cancer Hemoglobin > 6 g/dl Not at risk for pregnancy No desire for future fertility Willing and able to complete the follow-up requirements outlined in the study design section of the protocol Willing to sign a consent form Exclusion Criteria: Subserosal fibroids. Any fibroid that obstructs access to the endometrial cavity FSH > 20 IU/L Pregnancy Evidence of disorders of hemostasis Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen SERMS/SPRMS within the last 6 months Current use of any IUD or use of Mirena IUS within the last 3 months Gynecological malignancy or hyperplasia Known/suspected abdominal/pelvic cancer Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease) Adenomyosis Previous surgical or ablative treatment for fibroids or menorrhagia Previous uterine artery embolization or occlusion Patient on anti-coagulation therapy Needing emergency surgery to treat fibroid symptoms Concomitant intrauterine polyps. Major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data Contraindication to MRI Allergy to contrast media Mild renal insufficiency or worse Known renal disease Uncontrolled hypertension lasting 2 years or more Diabetes Uterine size > 10 weeks or 10 cm from ectocervix to fundus.

Ages Eligible for Study
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Minimum Age: 25 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

| Intervention/Treatment |
| --- |
|Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation|VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) |  | Baseline, 3 mo, 6 mo, 9 mo, 12 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of surgical reintervention |  | 12 mo | 
| Quality of Life questionnaires |  | Baseline, 3 mo, 6 mo, 9 mo, 12 mo | 
| Time required to return to normal daily activity |  | 7-14 days | 
| Adverse events |  | At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo. | 
| Subject tolerance of procedure rated via analog visual scale |  | Discharge | 
| Fibroid dimension and non-perfused volume |  | Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo | 
| Pregnancy and pregnancy-related complications |  | 3 mo, 6 mo, 9 mo, and 12 mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Fibroid RF Ablation, Intrauterine Ultrasound, VizAblate