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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.
Victoria General Hospital; Mature Women's Centre
Winnipeg, Manitoba, Canada
Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
Ottawa, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
Time frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Rate of surgical reintervention
Time frame: 12 mo
Quality of Life questionnaires
Time frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Time required to return to normal daily activity
Time frame: 7-14 days
Adverse events
Time frame: At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.
Subject tolerance of procedure rated via analog visual scale
Time frame: Discharge
Fibroid dimension and non-perfused volume
Time frame: Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo
Pregnancy and pregnancy-related complications
Time frame: 3 mo, 6 mo, 9 mo, and 12 mo
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.