Status:
TERMINATED
Open vs Robotic Assisted Partial Nephrectomy
Lead Sponsor:
Intuitive Surgical
Conditions:
Renal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients wit...
Detailed Description
Partial nephrectomy is the surgical removal of a kidney tumor while unaffected tissue remains intact so that the kidney function is maintained as far as possible. The more radical procedure would be t...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Patient with a renal tumor that is a candidate for OPEN surgery and robotic assisted surgery (RAS) partial nephrectomy (PN)
- R.E.N.A.L. score ≥ 7
- eGFR ≥ 50 ml/min/1.73 m²
- Anticoagulation is accepted according to the surgeon's practice
Exclusion
- Solitary kidney or functionally solitary kidney
- Prior surgery at the affected kidney excluding endoscopic kidney stone surgery
- Bilateral tumors
- Multiple renal tumors requiring excision
- Renal vein tumor thrombus
- Likely insufficient volume of remaining parenchyma after partial nephrectomy to maintain viable kidney remnant
- Metastatic disease with life expectancy of less than 1 year
- Pregnancy or suspected pregnancy
- Planned concomitant procedure
- Subject who is unable or unwilling to comply with the protocol requirements
- Subject considered to be from a vulnerable population according to IS0 14155:2011
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT03849820
Start Date
March 12 2019
End Date
October 25 2022
Last Update
June 17 2025
Active Locations (12)
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1
Dept. of Urology, University Hospital Tübingen
Tübingen, Germany, Germany, 72076
2
Department of Urology, University Hospital Düsseldorf
Düsseldorf, Germany, 40225
3
Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid
Essen, Germany, 45131
4
Department of Urology, University Hospital Freiburg
Freiburg im Breisgau, Germany, 79106