The goal of this study is to evaluate the safety \& efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.
Assaf Harofe
Zrifin, Israel
Improvement in patient's fibroid-related quality of life
To evaluate procedural efficacy by the improvement in patient's fibroid-related quality of life as assessed in scores of symptom severity subscale questionnaire (SSS-UFS-QOL) at 12 months post-treatment comparing to baseline score.
Time frame: 12 months
Incidence, subsequent interventions and procedure-related adverse events
To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment
Time frame: 12 months
Reduction in fibroid volume
Reduction in fibroid volume as measured by US/MRI imaging at 6 and 12 months follow-up post treatment comparing to baseline.
Time frame: 12 months
Improvement in menstrual bleeding
Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment.
Time frame: 12 months
Improvement in patient's fibroid-related quality of life
Improvement in patient's fibroid-related quality of life as assessed in scores of symptom severity subscale questionnaire (SSS-UFS-QOL) at 6 months post-treatment comparing to baseline score.
Time frame: 6 months
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