Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT07294859
Eligibility Criteria:
Inclusion Criteria:
* Fully understood and voluntarily signed the informed Consent Form (ICF);
* Age: \> 18 (at the time of signing the informed consent form); Gender is not limited.
* Preoperative eGFR \> 45ml/min/1.73m2 (corrected CKD-EPI formula);
* After the clinician formulates the treatment plan and communicates with the patient, they decide whether to perform radical nephrectomy or partial nephrectomy.
* ECOG score: 0-2 points;
* Be willing and able to abide by the visits, treatments, laboratory tests and other procedures of the research plan.
Exclusion Criteria:
* Patients with solitary kidney or severe contralateral renal insufficiency (eGFR \< 15ml/min/1.73m2);
* Preoperative reliance on renal replacement therapy (such as dialysis, etc.);
* Those who fail to complete the nephrectomy as planned during the operation;
* Patients with lymph node metastasis, distant metastasis or venous tumor thrombus;
* The healthy kidney has undergone radiotherapy, ablation or other surgeries.
* Have a history of allergy to ultrasound contrast agents;
* Have any contraindications for contrast-enhanced ultrasound, such as right-to-left shunt, severe pulmonary hypertension, etc.
* Patients with hemodynamic instability, including those with persistent hypotension (blood pressure \< 90/60 MMHG), uncontrollable heart failure, active bleeding (such as gastrointestinal and cerebral hemorrhage, etc.), or those with a bleeding tendency and hemoglobin \< 60g/L and/or platelet count \< 50×109/L;
* Accompanied by structural abnormalities of the urinary system or functional abnormalities that cannot be corrected in a short time (such as duplicate kidneys, polycystic kidneys, horseshoe kidneys, isolated kidneys, renal artery stenosis \> 50%, urinary tract obstruction, and previous history of kidney surgery, etc.), long-term indwelling of urinary catheters, etc.
* There are other diseases that limit life expectancy to less than six months;
* Previous (≤30 days before randomization) or concurrent participation in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07294859
Study Brief:
Protocol Section:
NCT07294859