Clinical trial · Interventional
Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma
ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial
NCT02399124CI-TRIAL-00100229ICE-SECRETactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This experiment is designed for post marketing data collection of a cryosurgical system \[PROSENSE™ of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PROSENSE™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- single arm, open label, treatment
- description
- single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance
- interventionNames
- Device: PROSENSE™
Primary outcomes (2)
- measure
- Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSense™ as seen under laparoscopic, US or CT imaging during the procedure.
- timeFrame
- During intervention
- description
- % of procedures with sufficient engulfment
- measure
- Recurrence free survival
- timeFrame
- up to 5 years
- description
- % of local recurrence events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is above 18 years old. 2. The patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging. 3. Patient's mass size is up to 5 cm at its largest dimension. 4. Patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure. 5. 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. Patients with permanent coagulation disorders or severe medical instability or active infection. 2. Patients with any terminal illness. 3. Patient participating in other trials using drugs or devices.
References
Publications (0)
Data not yet available
No reference posted for this study.