RECRUITINGINTERVENTIONAL
Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study
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
About This Trial
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?
Who May Be Eligible (Plain English)
Who May Qualify:
- Ages 18-80 years, regardless of gender
- Written willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
an AI-based real-time image-guided kidney model system
Use the AI-model to locate kidney and tumour, assisting surgeon with the operation
Locations (2)
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China