Off Clamp Randomization (NCT01732120) | Clinical Trial Compass
CompletedNot Applicable
Off Clamp Randomization
United States80 participantsStarted 2012-11
Plain-language summary
The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.
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:
* Patients 18 and older.
* Patients willing and able to sign consent.
* Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).
* Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.
Exclusion Criteria:
* Patients under 18.
* Patients with Karnofsky Performance Status (KPS) less than 40.
* Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).
* Patients with bilateral synchronous renal masses.
* Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.
* Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)
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
1
Percent Change From Baseline in eGFR
Timeframe: baseline and 3 months post nephrectomy
2
Percent Change From Baseline in Split Renal Function