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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    Use the AI-model to locate kidney and tumour, assisting surgeon with the operation

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: Conventional Surgical ApproachesNo intervention 0 interventions
Group B: AI model groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Operative Time

Time frame
Intraoperative

Secondary outcomes

1

Operating Surgeon's Assessment

Scoring for Each Surgery(0-5) by navigation accuracy, image rendering smoothness

Time frame
immediately after the surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shao Pengfei

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Southeast University, China

Collaborator