Tests an AI 3D kidney model to guide partial kidney removal in kidney cancer
Tests an AI 3D kidney model to guide partial kidney removal surgery.
Key facts
- Who runs it
- Shao Pengfei
- Where
- Nanjing, ChinaSee the site
- Trial code
- Registry title
- Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study
- Status
- Recruiting
- People taking part
- 232 people, planned
- Started
- 1 May 2025
- Expected to end
- 1 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- an AI-based real-time image-guided kidney model system
- Record updated
- 13 June 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a single kidney tumor that has not spread, who are having keyhole (laparoscopic or robotic) surgery to remove part of the kidney.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Clinical stage T1a or select T1b kidney tumor, shown on CT or MRI, with an R.E.N.A.L. nephrometry score of 10 or less. No spread to lymph nodes or distant organs.
- Earlier treatment
- No anticancer drug treatment (targeted agents, immunotherapy or chemotherapy) within the last 6 months.
Main reasons for not taking part
- Kidney tumors in more than one spot (bilateral or unilateral)
- Anticancer drug treatment within 6 months
- Conditions that rule out surgery, such as ASA class IV or higher or uncontrolled bleeding disorder
- Serious heart failure (NYHA class III/IV) or eGFR below 30 mL/min/1.73m²
- Taking part in another interventional clinical trial
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior systemic anticancer therapy (targeted agents/immunotherapy/chemotherapy) within 6 months
- Absolute surgical contraindications (e.g., ASA class ≥IV, uncontrolled coagulopathy)
- Postoperative adjuvant therapy during protocol-defined follow-up (12 months)
- Concurrent enrollment in interventional clinical trials
- Major comorbidities (e.g., NYHA class III/IV heart failure, eGFR <30 mL/min/1.73m²) affecting outcome assessment
- Multifocal renal tumors (bilateral or unilateral)
- Intraoperative conversion to radical nephrectomy or open approach
- Investigator-determined ineligibility based on risk-benefit analysis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)Nanjing, ChinaContact: Pengfei Shao, ProfessorNot yet recruiting
About the trial
What the trial wants to find out
The goal of this study is to develop a real-time artificial intelligence-driven 3D kidney model to assist robotic or laparoscopic partial nephrectomy:
Read full original descriptionShow less
• Can this AI-powered model optimize the workflow of partial nephrectomy and enhance surgical benefits?
The 2 groups in the trial
- Conventional Surgical ApproachesNo study treatment, for comparison
perform conventional laparoscopic or robotic-assisted surgical approaches
- AI model groupTreatment being tested
Use the AI-model to locate kidney and tumour, assisting surgeon with the operation
Treatment: an AI-based real-time image-guided kidney model system
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests an AI 3D kidney model to guide partial kidney removal in kidney cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07020169, who can take part
- Record updated
- 13 June 2025