A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial

Status Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to evaluate peri and post-operative outcomes as well as long-term survival of 3D IGRAPN compared to conventional Robot-Assisted Partial Nephrectomy (RAPN) for moderate and highly complex renal tumors. The main questions aim to answer: - peri-operative complications - oncological safety - long term renal function Participants will be asked to do undergo 3D-IGRAPN. Researchers will compare 3D-IGRAPN to RAPN to see if peri-operative outcomes are better in the experimental group.

Clinical Trial Description

Robot-assisted partial nephrectomy (RAPN) is the standard treatment for localized kidney tumors. New 3D modeling and reconstruction technologies have enabled the development of real time imageguided surgery using virtual reality (VR). In view of advances in artificial intelligence and surface recognition based on deep-learning, augmented reality (AR) by merging a 3D reconstructed virtual image onto the real per-operative view represents the next step in image-guided surgery. 3D IG-RAPN using Synapse 3D (Fujifilm) and DaVinci Tile-Pro display (Intuitive Surgical) vs conventional RAPN without 3D navigation in 12 high-volume urological centers from the UroCCR Network. Outcoume : Primary endpoint is a composite validated score (TRIFECTA) evaluating peri-operative complications as well as oncological safety and long-term renal function preservation. Secondary endpoints assess long-term survival, ergonomics and surgeon satisfaction. A medico-economic evaluation will be performed. Methodology: ACCURATE is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling 694 patients with a single complex renal mass, defined as RENAL NS≥7. Randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05572216
Study type	Interventional
Source	University Hospital, Grenoble
Contact	Jean-Alexandre LONG, Pr
Phone	0476767642
Email	jalong@chu-grenoble.fr
Status	Not yet recruiting
Phase	N/A
Start date	December 2022
Completion date	November 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99) — ACCURATE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms