ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses
Recruiting
N/AInterventional Study
Renal Cell Carcinoma (RCC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
59 (estimated)
Sponsor
University of Florida · Other
Who this trial is looking for
This trial is looking for adult patients with kidney tumors who may need surgery. If you join, you'll undergo a new type of kidney surgery that aims to preserve kidney function without traditional methods like clamping and suturing.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have a kidney tumor that is 7 cm or smaller.
I do not have more than one active cancer.
I have been diagnosed with renal cell carcinoma without blood clots in the vein.
My platelet count is over 50,000/µL.
My hemoglobin level is over 9.0 g/dL.
I can give written consent and follow study procedures.
I am using birth control or my partner is using contraception.
You may not be able to join if
I have a bleeding disorder.
I have severe liver disease.
I have blood clots in my renal vein.
I have end-stage kidney disease or need dialysis.
I cannot use birth control during the study and for 2 weeks after surgery.
I am currently pregnant or breastfeeding.
I have a medical condition that might complicate the study.
I am a prisoner or involuntarily detained.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. It is possible to perform this procedure without clamping the hilum and also without formal renorrhaphy.…
During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. It is possible to perform this procedure without clamping the hilum and also without formal renorrhaphy. However robust prospective formal evaluation of safety, risks, and potential benefits and whether or not the technique can be employed in a generalized fashion has not been studied.
Demonstration of safety and generalizability may open a whole new avenue of approaching nephron sparing and renal function sparing kidney surgery and decrease potential risks for long term kidney disease in patients with renal masses. This study will investigate the safety, efficacy, and generalizability of the use of clampless, sutureless partial nephrectomy in the treatment of renal cell carcinoma.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults ≥ 18 years of age.
* Patients undergoing partial nephrectomy for renal masses ≤ 7 cm
* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the …
Inclusion Criteria:
* Adults ≥ 18 years of age.
* Patients undergoing partial nephrectomy for renal masses ≤ 7 cm
* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician or approved by the Principal Investigator\] may be included).
* A clinical diagnosis consistent with renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus.
* Adequate laboratory test results, including:
1. Platelets \> 50,000/µL
2. Hemoglobin \> 9.0 g/dL
* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
* Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 2 weeks after surgery to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
* Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 2 weeks following surgery.
Exclusion Criteria:
* Bleeding disorder (any congenital bleeding diathesis)
* Liver dysfunction with end stage liver disease as determined by the treating investigator
* Presence of renal vein thrombus
* End stage renal disease (eGFR \< 15 using Cockcroft-gault formula or receiving renal replacement therapy (i.e. dialysis))
* Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 2 weeks after surgery.
* Subjects who are confirmed to be pregnant or breastfeeding.
* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
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