CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 45 enrolled
Drug / intervention
Mixed Realitycombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06903260
NCT06903260Phase 3Completed

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

Hospital Moinhos de Vento·interventional·Posted Mar 30, 2025·Updated Mar 30, 2025

In Brief

A Phase 3 clinical trial evaluating Mixed Reality for Kidney Cancer. Completed, enrolled 45 participants across 1 site.

Detailed Summary

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 of RAPN. To analyze the efficacy of MIXREAL, the investigators intended to allocate forty-five patients with renal lesions to RAPN with, Realitatem Group (RG), or without, Control Group (CG), use of MIXREAL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesBrazil

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMar 30, 2025
Enrollment StartAug 1, 2022
Primary CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 1.3 years ago

Interventions

Mixed Realitycombination

Virtual reality (VR) is defined as an artificial 3D visual environment and augmented reality (AR), as virtual objects superimposed on the real world; mixed reality is the association between VR and AR. The images were exported from CT image in DICOM (Digital Imaging and Communications in Medicine) and applied in Brainlab Elements software (Brainlab AG, Munich, Germany), where the images and 3D drawing were rendered in partnership with the collaborating bioengineer of this work to obtain the VR. AG was obtained during the intraoperative through the Magic Leap 1 goggle (Magic Leap Inc., Plantation, FL, USA)