Actively Recruiting
ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses (CASPIAN)
Led by University of Florida · Updated on 2026-06-08
59
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new surgical technique called clampless, sutureless partial nephrectomy for patients with renal cell carcinoma. This approach aims to preserve kidney function by avoiding clamping of the kidney's blood supply and suturing during partial kidney removal. The study will assess the safety, risks, potential benefits, and whether this technique can be broadly applied in treating kidney tumors up to 7 cm in size. All participants will undergo the clampless, sutureless robotic partial nephrectomy procedure. The study will monitor outcomes such as positive surgical margins and transfusion rates within weeks after surgery. Additional assessments include kidney function and blood loss at various time points up to six months post-surgery. Participants will be closely followed with laboratory tests and clinical evaluations before and after surgery. Researchers will measure kidney function shortly after surgery and during follow-up visits, along with blood loss and the need for blood transfusions. The study will also monitor safety and any complications related to the surgical method throughout the observation period, which extends up to six months after surgery.
CONDITIONS
Brief 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 undergoing partial nephrectomy for renal masses 7 cm or smaller
- No more than one active cancer at enrollment, except certain prior or concurrent cancers that do not interfere with study assessment
- Clinical diagnosis of renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus
- Adequate lab results: platelets over 50,000/µL and hemoglobin over 9.0 g/dL
- Willingness to provide informed consent and comply with study procedures
- Use of effective contraception during the study and for at least 2 weeks after surgery if of childbearing potential or having a partner who is
You will not qualify if you...
- Bleeding disorders or congenital bleeding problems
- Liver dysfunction with end stage liver disease
- Presence of renal vein thrombus
- End stage kidney disease (eGFR below 15 or on dialysis)
- Unwilling or unable to use contraception if of childbearing potential
- Confirmed pregnancy or breastfeeding
- Any other disease or clinical condition that, in the opinion of the treating physician, contraindicates study therapy or affects result interpretation
- Prisoners, involuntarily incarcerated individuals, or those compulsorily detained for treatment of psychiatric or physical illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 weeks
Participants undergo a clampless, sutureless robotic partial nephrectomy and receive immediate care after surgery.
1 surgery visit and approximately 2 to 3 follow-up visits within 4 weeks
Duration - Up to 6 months
Participants are monitored for longer-term outcomes including renal function and recovery after surgery.
1 visit at 6 months post-surgery
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
P
Pravalika Manda
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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