Status:
UNKNOWN
Efficacy and Safety of IRE for RMs
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between t...
Detailed Description
Rationale: The past decades have shown an increase in the incidence of small renal masses (SRM). At the moment laparoscopic partial nephrectomy is the 'golden standard' in treatment of SRMs. Thermal ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Solid, enhancing mass on cross sectional imaging
- Scheduled for a radical nephrectomy, open or laparoscopic.
- Signed informed consent
Exclusion
- Irreversible bleeding disorders
- Inability/unwillingness to interrupt anticoagulation therapy
- Previous cryoablation, RFA or partial nephrectomy in affected kidney
- Anaesthesia Surgical Assignment (ASA), category ≤ IV
- ICD / pacemaker
- Severe cardiovascular disease in medical history
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02298608
Start Date
January 1 2014
End Date
December 1 2016
Last Update
November 24 2014
Active Locations (1)
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1
Dept. Urology, Academic Medical Center, Amsterdam
Amsterdam, Netherlands