TerminatedNot Applicable

Open vs Robotic Assisted Partial Nephrectomy

Stopped: Due to low enrollment the study was terminated

Germany247 participantsStarted 2019-03-12

Plain-language 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 with intermediate to high complexity kidney tumors.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

30 day complications

Timeframe: Day of surgery to 30th post operative day

Trial details

NCT IDNCT03849820

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-15

View on ClinicalTrials.gov More Renal Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.