AI-driven real-time 3D kidney model to assist partial nephrectomy
Artificial Intelligence-Driven 3D Kidney Model for Real-Time Augmented Reality and Surgical Navigation in Minimally Invasive (Robotic/Laparoscopic) Partial Nephrectomy: A Prospective Validation Study
This trial will test whether an AI-powered real-time 3D kidney model can help surgeons perform laparoscopic or robotic partial nephrectomy for adults with small, localized kidney tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT07020169 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized study compares intraoperative AI-assisted navigation using an automated, real-time 3D kidney model overlay with conventional laparoscopic or robotic partial nephrectomy. Eligible patients with clinical T1a or selected T1b renal tumors will be randomized to receive either the AI-guided approach or standard care. Primary comparative metrics include warm ischemia time, positive margin rate, and operative efficiency indices, with system refinements guided by clinical performance feedback. Findings will inform feasibility and iterative development of the image-guided surgical platform.
Who should consider this trial
Good fit: Adults aged 18–80 with localized T1a or selected T1b renal tumors scheduled for elective minimally invasive partial nephrectomy and able to provide informed consent are ideal candidates.
Not a fit: Patients with multifocal tumors, recent systemic anticancer therapy, major surgical contraindications, or who require conversion to radical or open surgery are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the system could shorten ischemia time, improve margin control, and make partial nephrectomy safer and more efficient.
How similar studies have performed: Small feasibility and pilot studies of 3D models and augmented-reality overlays in kidney surgery have shown technical feasibility and promising reductions in ischemia time, but randomized clinical evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital) — Nanjing, Jiangsu, China (Not_yet_recruiting)
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital) — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Pengfei Shao, Professor
- Email: spf032@hotmail.com
- Phone: +8613851925825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.