ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses

Phase 1

Not yet recruiting

• Conditions: Renal Cell Carcinoma (RCC)

• Registration Number: NCT06722807
• Lead Sponsor: University of Florida

Brief Summary

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 hi...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-03
• Primary Completion: 2026-08
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Positive margin rate	2-3 weeks post-surgery	Determine the positive margin rate, as measured on the pathology report 2-3 weeks post-surgery.
Transfusion rate	4 weeks post-surgery	Determine the transfusion rate, as measured approximately 4 weeks post-surgery via review of patient medical records.

Secondary Outcome Measures

Name	Time	Method
Renal dysfunction (1 day post-surgery)	1 day post-surgery	Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 1-day post-surgery.
Renal dysfunction (2-3 weeks post-surgery)	2-3 weeks post-surgery	Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 2-3 weeks post-surgery.
Renal dysfunction (6 months post-surgery)	6 months post-surgery	Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 6 months post-surgery.
Estimated blood loss	at time of partial nephrectomy	Determine the estimated blood loss, as determined on the operative report.
Need for ischemia	at time of partial nephrectomy	Determine how many subjects have a need for ischemia, as determined by need to clamp or not.