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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional · Phase 3
• Participants enrolled: 45
• From 1 Aug 2022 to the primary completion date, 1 Jan 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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