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

Sponsors and collaborators

Shao Pengfei

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Southeast University, China

Collaborator