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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT07020169
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-80 years, regardless of gender
* Written informed consent obtained from the patient or legally authorized representative after full protocol disclosure
* Preoperative imaging (CT/MRI) confirming clinical stage T1a or select T1b renal tumors suitable for partial nephrectomy (R.E.N.A.L. nephrometry score ≤10)
* Localized renal tumors without lymph node/distant metastasis per NCCN Guidelines® (v2023)
* Elective minimally invasive partial nephrectomy (laparoscopic/robotic) after comprehensive surgical counseling
Exclusion Criteria:
* Multifocal renal tumors (bilateral or unilateral)
* Prior systemic anticancer therapy (targeted agents/immunotherapy/chemotherapy) within 6 months
* Absolute surgical contraindications (e.g., ASA class ≥IV, uncontrolled coagulopathy)
* Intraoperative conversion to radical nephrectomy or open approach
* Postoperative adjuvant therapy during protocol-defined follow-up (12 months)
* Major comorbidities (e.g., NYHA class III/IV heart failure, eGFR \<30 mL/min/1.73m²) affecting outcome assessment
* Concurrent enrollment in interventional clinical trials
* Investigator-determined ineligibility based on risk-benefit analysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07020169
Study Brief:
Protocol Section:
NCT07020169