AI-driven real-time 3D kidney model to assist partial nephrectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
  Nanjing, Jiangsu, China Recruiting
• The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
  Nanjing, Jiangsu, China Not yet recruiting

Study contacts

• Study coordinator: Pengfei Shao, Professor
• Email: spf032@hotmail.com
• Phone: +8613851925825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.