ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06722807
Status
Recruiting
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Conditions

  • Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sutureless, clampless partial nephrectomy — PROCEDURE
    All subjects will undergo a clampless, sutureless robotic partial nephrectomy.

Study Details

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.

Key Dates

Start date
Jun 10, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Clampless, sutureless robotic partial nephrectomy

Primary Outcome Measure

Positive margin rate [ Time Frame: 2-3 weeks post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Pravalika Manda
[email protected]
352-265-9728
Padraic O'Malley (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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