Symptomatic Uterine Fibroids
Conditions
Keywords
cryoablation, uterine fibroid, uterine myoma, who completed her family planning, but wishes to preserve her uterus
Brief summary
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.
Interventions
DEVICEIceSense3 system
The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.
Sponsors
IceCure Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Pre-menopausal woman between the ages of 30 and 50 (inclusive) 2. Patient had completed her family planning and does not desire future childbearing. 3. Patient is suffering from menorrhagia as a result of symptomatic uterine fibroids. 4. Patient's uterus size is smaller than 18 gestational weeks. 5. Patient wishes to preserve her uterus and avoid hysterectomy. 6. Patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by US/MRI. 7. Overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523) 8. Patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment. 9. Patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment. 10. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.
Exclusion criteria
1. Patient had not finished her family planning 2. Patient was already treated for uterine fibroids in the past (UAE, myomectomy, HIFU,…) or undergone endometrial ablation. 3. Patient had been treated with GnRH over the last 3 months. 4. Patient has known symptomatic endometriosis that cannot be completely removed during laparoscopic procedure. 5. Patient has known or suspected adenomyosis 6. Patient had any active abdominal/pelvic inflammatory disease. 7. Patient has known or suspected gynecologic malignancy. 8. Patient with submucosal fibroids type zero 9. Patient with undiagnosed vaginal bleeding 10. Patient with blood clotting disorders 11. Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS. 12. Patient participating in other trials using drugs or devices. 13. Patient is unable to commit all study requirements including follow-up visits and questionnaires. 14. Patient has any contraindication for laparoscopic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in patient's fibroid-related quality of life | 12 months | 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. |
| Incidence, subsequent interventions and procedure-related adverse events | 12 months | To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in patient's fibroid-related quality of life | 6 months | 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. |
| Improvement in menstrual bleeding | 12 months | Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment. |
| Reduction in fibroid volume | 12 months | Reduction in fibroid volume as measured by US/MRI imaging at 6 and 12 months follow-up post treatment comparing to baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's and physician's overall treatment evaluation | 12 months | Patient's and physician's overall treatment evaluation and satisfaction will be assessed using a self-report questionnaire at 6 and 12 months post treatment. |
| Patient blood loss | 12 months | Patient blood loss will be also evaluated by Hemoglobin (Hb) level measurements at 6 and 12 months post treatment and will be compared to baseline. |
Countries
Israel
Outcome results
None listed