Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study
Recruiting now · Not applicable
Conditions studied: Renal Cell Cancer
In brief
The goal of this study is to develop a real-time artificial intelligence-driven 3D kidney model to assist robotic or laparoscopic partial nephrectomy: • Can this AI-powered model optimize the workflow of partial nephrectomy and enhance surgical benefits?
Key facts
- Study ID
- NCT07020169
- Run by
- Shao Pengfei
- People needed
- 232
- Starts
- 2025-05-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2025-06-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital) — Nanjing, Jiangsu, China (enrolling)
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital) — Nanjing, Jiangsu, China
Full record on ClinicalTrials.gov
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