Actively Recruiting
Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study
Led by Shao Pengfei · Updated on 2025-06-13
232
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
S
Shao Pengfei
Lead Sponsor
S
Southeast University, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 80 years, any gender
- Written informed consent given after full explanation of the study
- Preoperative CT or MRI confirming clinical stage T1a or selected T1b kidney tumors suitable for partial nephrectomy (R.E.N.A.L. score 60)
- Localized kidney tumors without lymph node or distant spread as per NCCN Guidelines (v2023)
- Planned elective minimally invasive partial nephrectomy (laparoscopic or robotic) after detailed surgical counseling
You will not qualify if you...
- Multifocal kidney tumors in one or both kidneys
- Systemic anticancer treatments (targeted, immunotherapy, chemotherapy) within 6 months before surgery
- Absolute surgical contraindications such as ASA class IV or higher, or uncontrolled bleeding risk
- Intraoperative change to radical nephrectomy or open surgery
- Receiving postoperative adjuvant therapy during the 12-month follow-up
- Major comorbid conditions like severe heart failure (NYHA class III/IV) or very low kidney function (eGFR <30 mL/min/1.73m2)
- Participation in other interventional clinical trials
- Investigator decides patient is not suitable based on risk and benefit assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China, 210036
Not Yet Recruiting
2
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China, 210036
Actively Recruiting
Research Team
P
Pengfei Shao, Professor
CONTACT
H
Haoqi Miao, Postgraduate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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