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| Name | Class |
|---|---|
| Bnai Zion Medical Center | OTHER_GOV |
| Assaf-Harofeh Medical Center | OTHER_GOV |
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This experiment is designed for post marketing data collection of a cryosurgical system [PROSENSEâ„¢ of IceCure Medical], for the treatment of renal cell carcinoma (RCC).
A post marketing data collection of a cryosurgical system [PROSENSEâ„¢] of IceCure Medical], for the treatment of renal cell carcinoma (RCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm, open label, treatment | Other | single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROSENSEâ„¢ | Device | single arm, open label, PROSENSEâ„¢ treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSenseâ„¢ as seen under laparoscopic, US or CT imaging during the procedure. | % of procedures with sufficient engulfment | During intervention |
| Recurrence free survival | % of local recurrence events | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Success in verification of the ProSenseâ„¢ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones. | a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Halachmi Sarel, Prof. | Bnei Zion Medical Center, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnei Zion Medical Center | Haifa | Israel | ||||
| Shamir Medical Center |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Ẕerifin |
| 70300 |
| Israel |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |