Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShao Pengfei

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?

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • an AI-based real-time image-guided kidney model system

Treatment groups

232 Participants
are divided into 2 treatment groups

Locations

2
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)210036, NanjingJiangsu, China
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)210036, NanjingJiangsu, China

Sponsors and collaborators

Shao Pengfei

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Southeast University, China

Collaborator