Actively Recruiting
ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses
Led by University of Florida · Updated on 2025-06-26
59
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Patients scheduled for partial nephrectomy for renal masses 7 cm or smaller
- No more than one active malignancy at enrollment, except those not affecting study safety or results
- Clinical diagnosis of renal cell carcinoma, stage cT1-3 N0 M0 without renal vein thrombus
- Adequate platelets count above 50,000/µL
- Hemoglobin level above 9.0 g/dL
- Written informed consent given and agreement to follow study procedures
- Use of effective contraception for subjects of childbearing potential during the study and for at least 2 weeks after surgery
- Partners of subjects of childbearing potential must also use approved contraception during the study and for 2 weeks post-surgery
You will not qualify if you...
- Any bleeding disorder including congenital bleeding problems
- End stage liver disease as assessed by the treating investigator
- Presence of renal vein thrombus
- End stage renal disease with eGFR below 15 or on dialysis
- Subjects of childbearing potential who refuse or cannot use contraception during the study and for 2 weeks after surgery
- Pregnant or breastfeeding individuals
- Any other disease or condition that increases risk or affects study results as judged by the treating physician
- Prisoners or individuals involuntarily incarcerated or detained for psychiatric or physical illness
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
P
Pravalika Manda
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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