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Robot-assisted Partial Nephrectomy With and Without Mixed Reality (REALITATEM Study)

NCT06903260 · Hospital Moinhos de Vento · Updated 30 March 2025

What is being tested
Mixed Reality
For
Kidney Cancer
Kind of study
Tests a treatment or device on volunteers. Phase 3.
Who can join
Ages 18 years and older. About 45 people. The full rules are on the registry page.
Where
Brazil
When
Starts or started 1 Aug 2022, ends 1 Jan 2024. Registered 30 March 2025.
Results
None posted yet.

In the researchers' words

Kidney cancer has had a raising diagnostic incidence and partial nephrectomy (PN) is the standard of care for renal masses stage cT1a and a possible treatment choice for cT1b/T2; PN may be associated to a variety of tools, such as three-dimensional (3D) models, which can be used as printed models or through VR (virtual reality) and/or AR (augmented reality). Virtual reality is defined as an artificial 3D visual environment and AR, as virtual objects superimposed on the real world; mixed reality (MIXREAL) is the association between VR and AR. The first clinical experience using AR in a PN was in 2008, and since then, clinical trials of 3D assisted minimally invasive PN have been developed, such as the first trial evaluating both AR and VR in videolaparoscopic PN, a prospective cohort, and the first randomized clinical trial evaluating 3D model in robot assisted PN (RAPN), but using only VR; posteriorly, Porpiglia et al. and Li et al. published clinical trials of RAPN using AR. The investigators aimed to establish the improvements that use of MIXREAL can provide in perioperatory and functional outcomes of RAPN. Although previous studies have been showing positive results on behalf of 3D virtual models, besides this being the first study in Latin America to employ MIXREAL in minimally invasive PN, it is the first randomized clinical trial to employ both AR and VR in the context…
ClinicalTrials.gov, NCT06903260

Sites

  • Hospital Moinhos de VentoPorto Alegre, Brazil