Leiomyoma, Menorrhagia, Uterine Fibroids
Conditions
Keywords
Uterine Fibroid RF Ablation, Intrauterine Ultrasound, VizAblate
Brief summary
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.
Interventions
DEVICEVizAblate Intrauterine Ultrasound-Guided RF Ablation
VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.
Sponsors
Gynesonics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) | Baseline, 3 mo, 6 mo, 9 mo, 12 mo |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| Rate of surgical reintervention | 12 mo |
| 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 |
| Subject tolerance of procedure rated via analog visual scale | Discharge |
Countries
Canada
Outcome results
None listed