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

NCT06903260 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

Mixed Reality

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)

Sponsors & Collaborators

  • Brainlab AG

    collaborator INDUSTRY

  • Magic Leap Inc

    collaborator UNKNOWN

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Andre Kives Berger, MSc · Hospital Moinhos de Vento

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-01-01
Completion
2024-01-01
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903260 on ClinicalTrials.gov