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The goal of this study is to evaluate the safety & efficacy of cryoablation using IceCure medical's IceSense3â„¢ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symptomatic UF | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IceSense3 system | Device | The IceSense3â„¢ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Improvement in menstrual bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's and physician's overall treatment evaluation | 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. | 12 months |
| Patient blood loss |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moty Pansky, Prof. | Assaf Harofe Hospital, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofe | Zrifin | 70300 | Israel |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment.
| 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. | 6 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.
| 12 months |
| D009372 | Neoplasms, Connective Tissue |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |