NCT06056505

Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy

Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - a Multicentre, Randomised, Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.

Detailed description

3DPN is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3D modelling with the 2D modelling in robotic-assisted partial nephrectomy. According to the randomisation the 3D or 2D modelling is used for patient information (before intervention) and for partial nephrectomy. A six-month follow-up visit is provided.

Conditions

• Kidney Tumor

Interventions

Type	Name	Description
PROCEDURE	partial kidney nephrectomy	surgery for partial nephrectomy
DEVICE	DaVinci Robot	device to perform the surgery for partial nephrectomy (not the intervention of interest)
DEVICE	Innersight 3D software	investigational product to generate the 3D model

Timeline

• Start date: 2023-10-24
• Primary completion: 2026-03-31
• Completion: 2026-09-30
• First posted: 2023-09-28
• Last updated: 2024-12-09

Locations

8 sites across 1 country: Germany