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

NCT06903260 | Completed Phase 3 DMC FDA Device

• 1 other identifier: 66791623.8.0000.5330
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Kidney Cancer

Keywords

Robot-assisted Partial Nephrectomy; Mixed Reality; Augmented Reality; Virtual Reality; Ischemia Time

Outcome Measures

Primary Outcomes (1)

• ischemia time

  time from renal artery clamping to its disclamping

  "Perioperative/Periprocedural"

Secondary Outcomes (8)

• total surgical time

  "Perioperative/Periprocedural"

• conversion to open surgery

  "Perioperative/Periprocedural"

• artery clamping

  "Perioperative/Periprocedural"

• selective clamping

  "Perioperative/Periprocedural"

• estimated blood loss

  "Perioperative/Periprocedural"

Study Arms (2)

Realitatem Group

EXPERIMENTAL

robot assisted partial nephrectomy with use of mixed reality

Combination Product: Mixed Reality

Control group

NO INTERVENTION

robot assisted partial nephrectomy with out use of mixed reality

Interventions

Mixed Reality COMBINATION_PRODUCT

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)

Realitatem Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients above 18 years old with solid renal masses or complex renal cysts Bosniak III/IV requiring partial nephrectomy

You may not qualify if:

• solid renal masses or complex renal cysts Bosniak III/IV with initial indication of radical nephrectomy

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead
• Brainlab AG: collaborator
• Magic Leap Inc: collaborator

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Brazil

Location

Related Publications (29)

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MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Andre Kives Berger, MSc

  Hospital Moinhos de Vento

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient's accrual occurred in the private clinic of a few urologists, and patients were blinded to the intervention they would be submitted to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 30, 2025
• Study Start: August 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-02

Locations

BR (1)