Kidney CancerPhase 3NCT06903260
Robot-assisted Partial Nephrectomy With and Without Mixed Reality (REALITATEM Study)
A Phase 3 study testing Mixed Reality in people with Kidney Cancer, run by Hospital Moinhos de Vento at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Mixed Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2022to 1 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients above 18 years old with solid renal masses or complex renal cysts Bosniak III/IV requiring partial nephrectomy
Who cannot join
- solid renal masses or complex renal cysts Bosniak III/IV with initial indication of radical nephrectomy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
Patient's accrual occurred in the private clinic of a few urologists, and patients were blinded to the intervention they would be submitted to. The randomization process was done in a manual pattern, where the next case would always be enrolled to a different group than the previous, starting the study with a patient enrolled to RG.
Besides sociodemographic data, pre-operative data regarding the tumor also was collected and it was determined by an updated CT, done within one month from the surgery. Patients randomized to RG were specifically required an angioCT. The images were exported 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 (Figure 1). Planned cases were available via cloud services for immediate use in the operating room (www.brainlab.com).
All surgeries were robot-assisted, conducted transperitoneally, and executed at Moinhos de Vento Hospital (Porto Alegre, Rio Grande do Sul), a tertiary center, from August 2022 to January 2024 by 8 urologists with experience in RAPN. AG was obtained through the Magic Leap 1 goggle (Magic Leap Inc., Plantation, FL, USA) (Figure 5); the only role Brainlab and Magic Leap industries had in this study was the providing of the software and the goggle free of charge.
Besides tumor and patient's baseline characteristics and intra-operative data, such as vessel clamping, ischemia time, estimated blood loss (EBL), use of hemostatic agents and excision technique, post-operative data, such as renal function, anatomopathology, complication rate and hospital staying, were also recorded. Our primary endpoint was ischemia time and the rest were secondary endpoints.
The results obtained were stored in a confidential database, with exclusive access to the researchers, and later organized in the Statistical Package for the Social Sciences (SPSS), proceeding to statistical analyzes.
Initially, descriptive analyzes were performed to characterize the sample of participants. Later, comparisons were made between GR and GC through non-parametric tests Mann-Whitney, Chi-square (CH2) and, when necessary, Fisher's exact test. These comparisons constituted homogeneity analyzes between the groups in the case of sociodemographic, preoperative and histopathological characteristics, while in the perioperative and functional variables they served to find a possible difference related to whether or not to use MIXREAL. For all analyzes performed, it was adopted the 95% confidence interval and the significance level of 5% (p ≤ .05).
The sample was calculated using the Risk Calc software. Assuming a difference in mean ischemia rate (primary outcome) between treatment groups to be 3.9 minutes (20), an expected population standard deviation to be 3.23 (11) and a clinically relevant difference to be of 1 minute (22), to achieve 80% power (i.e., 1-β=0.8) at the level of significance of 5% (α=0.05) with equal allocation (i.e., k=1) and dropout rate of 5%, a total sample of at least 34 patients, divided into two groups, would be required
- Conditions
- Kidney Cancer
- Being tested
- Mixed Reality
- Keywords
- Robot-assisted Partial Nephrectomy, Mixed Reality, Augmented Reality, Virtual Reality, Ischemia Time
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed RealityCombination 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)
| Study group | Role | What they receive |
|---|---|---|
| Realitatem Group | Experimental | robot assisted partial nephrectomy with use of mixed reality Receives: Combination Product: Mixed Reality |
| Control group | No intervention | robot assisted partial nephrectomy with out use of mixed reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemia time
time from renal artery clamping to its disclamping
Measured: "Perioperative/Periprocedural"
Secondary outcomes (8)
total surgical time
from first skin incision to skin suture
Measured: "Perioperative/Periprocedural"
conversion to open surgery
conversion to open surgery
Measured: "Perioperative/Periprocedural"
artery clamping
need of artery clamping or off clamp
Measured: "Perioperative/Periprocedural"
selective clamping
clamping of a renal artery branch, instead of the main renal artery
Measured: "Perioperative/Periprocedural"
estimated blood loss
in ml
Measured: "Perioperative/Periprocedural"
excision technique
Wedge resection or Enucleoresection or Enucleation
Measured: "Perioperative/Periprocedural"
conversion to radical nephrectomy
yes or no
Measured: "Perioperative/Periprocedural"
perioperative complication
according to clavien-dindo classification
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Aug 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Collaborators
- Brainlab AG, Magic Leap Inc
- Responsible party
- Sponsor
- Investigators
- Andre Kives Berger, MSc, Study chair, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903260
- Sponsor's protocol ID
- 66791623.8.0000.5330
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Palumbo C, Pecoraro A, Knipper S, Rosiello G, Luzzago S, Deuker M, Tian Z, Shariat SF, Simeone C, Briganti A, Saad F, Berruti A, Antonelli A, Karakiewicz PI. Contemporary Age-adjusted Incidence and Mortality Rates of Renal Cell Carcinoma: Analysis According to Gender, Race, Stage, Grade, and Histology. Eur Urol Focus. 2021 May;7(3):644-652. doi: 10.1016/j.euf.2020.05.003. Epub 2020 May 23.
PubMed 32456993Bukavina L, Bensalah K, Bray F, Carlo M, Challacombe B, Karam JA, Kassouf W, Mitchell T, Montironi R, O'Brien T, Panebianco V, Scelo G, Shuch B, van Poppel H, Blosser CD, Psutka SP. Epidemiology of Renal Cell Carcinoma: 2022 Update. Eur Urol. 2022 Nov;82(5):529-542. doi: 10.1016/j.eururo.2022.08.019. Epub 2022 Sep 10.
PubMed 36100483Motzer RJ, Jonasch E, Boyle S, Carlo MI, Manley B, Agarwal N, Alva A, Beckermann K, Choueiri TK, Costello BA, Derweesh IH, Desai A, George S, Gore JL, Haas N, Hancock SL, Kyriakopoulos C, Lam ET, Lau C, Lewis B, Madoff DC, McCreery B, Michaelson MD, Mortazavi A, Nandagopal L, Pierorazio PM, Plimack ER, Ponsky L, Ramalingam S, Shuch B, Smith ZL, Somer B, Sosman J, Dwyer MA, Motter AD. NCCN Guidelines Insights: Kidney Cancer, Version 1.2021. J Natl Compr Canc Netw. 2020 Sep;18(9):1160-1170. doi: 10.6004/jnccn.2020.0043.
PubMed 32886895Wake N, Nussbaum JE, Elias MI, Nikas CV, Bjurlin MA. 3D Printing, Augmented Reality, and Virtual Reality for the Assessment and Management of Kidney and Prostate Cancer: A Systematic Review. Urology. 2020 Sep;143:20-32. doi: 10.1016/j.urology.2020.03.066. Epub 2020 Jun 12.
PubMed 32535076Detmer FJ, Hettig J, Schindele D, Schostak M, Hansen C. Virtual and Augmented Reality Systems for Renal Interventions: A Systematic Review. IEEE Rev Biomed Eng. 2017;10:78-94. doi: 10.1109/RBME.2017.2749527. Epub 2017 Sep 6.
PubMed 28885161Ukimura O, Gill IS. Imaging-assisted endoscopic surgery: Cleveland Clinic experience. J Endourol. 2008 Apr;22(4):803-10. doi: 10.1089/end.2007.9823.
PubMed 18366316Wang D, Zhang B, Yuan X, Zhang X, Liu C. Preoperative planning and real-time assisted navigation by three-dimensional individual digital model in partial nephrectomy with three-dimensional laparoscopic system. Int J Comput Assist Radiol Surg. 2015 Sep;10(9):1461-8. doi: 10.1007/s11548-015-1148-7. Epub 2015 Jan 11.
PubMed 25577366Shirk JD, Thiel DD, Wallen EM, Linehan JM, White WM, Badani KK, Porter JR. Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911598. doi: 10.1001/jamanetworkopen.2019.11598.
PubMed 31532520Porpiglia F, Checcucci E, Amparore D, Piramide F, Volpi G, Granato S, Verri P, Manfredi M, Bellin A, Piazzolla P, Autorino R, Morra I, Fiori C, Mottrie A. Three-dimensional Augmented Reality Robot-assisted Partial Nephrectomy in Case of Complex Tumours (PADUA >/=10): A New Intraoperative Tool Overcoming the Ultrasound Guidance. Eur Urol. 2020 Aug;78(2):229-238. doi: 10.1016/j.eururo.2019.11.024. Epub 2019 Dec 30.
PubMed 31898992Li L, Zeng X, Yang C, Un W, Hu Z. Three-dimensional (3D) reconstruction and navigation in robotic-assisted partial nephrectomy (RAPN) for renal masses in the solitary kidney: A comparative study. Int J Med Robot. 2022 Feb;18(1):e2337. doi: 10.1002/rcs.2337. Epub 2021 Oct 10.
PubMed 34591353Yoshida S, Sugimoto M, Fukuda S, Taniguchi N, Saito K, Fujii Y. Mixed reality computed tomography-based surgical planning for partial nephrectomy using a head-mounted holographic computer. Int J Urol. 2019 Jun;26(6):681-682. doi: 10.1111/iju.13954. Epub 2019 Mar 25. No abstract available.
PubMed 30912180Edgcumbe P, Singla R, Pratt P, Schneider C, Nguan C, Rohling R. Follow the light: projector-based augmented reality intracorporeal system for laparoscopic surgery. J Med Imaging (Bellingham). 2018 Apr;5(2):021216. doi: 10.1117/1.JMI.5.2.021216. Epub 2018 Feb 14.
PubMed 29487888Porpiglia F, Fiori C, Checcucci E, Amparore D, Bertolo R. Hyperaccuracy Three-dimensional Reconstruction Is Able to Maximize the Efficacy of Selective Clamping During Robot-assisted Partial Nephrectomy for Complex Renal Masses. Eur Urol. 2018 Nov;74(5):651-660. doi: 10.1016/j.eururo.2017.12.027. Epub 2018 Jan 6.
PubMed 29317081Scosyrev E, Messing EM, Sylvester R, Campbell S, Van Poppel H. Renal function after nephron-sparing surgery versus radical nephrectomy: results from EORTC randomized trial 30904. Eur Urol. 2014 Feb;65(2):372-7. doi: 10.1016/j.eururo.2013.06.044. Epub 2013 Jul 2.
PubMed 23850254Alrumayyan M, Raveendran L, Lawson KA, Finelli A. Cystic Renal Masses: Old and New Paradigms. Urol Clin North Am. 2023 May;50(2):227-238. doi: 10.1016/j.ucl.2023.01.003. Epub 2023 Feb 20.
PubMed 36948669
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Partial Nephrectomy With and Without Mixed Reality (REALITATEM Study)
- ClinicalTrials.gov ID
- NCT06903260
- Acronym / sponsor ID
- 66791623.8.0000.5330
- Conditions
- Kidney Cancer
- Keywords
- Robot-assisted Partial Nephrectomy, Mixed Reality, Augmented Reality, Virtual Reality, Ischemia Time
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Collaborators
- Brainlab AG, Magic Leap Inc
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Patient's accrual occurred in the private clinic of a few urologists, and patients were blinded to the intervention they would be submitted to. The randomization process was done in a manual pattern, where the next case would always be enrolled to a different group than the previous, starting the study with a patient enrolled to RG.
Besides sociodemographic data, pre-operative data regarding the tumor also was collected and it was determined by an updated CT, done within one month from the surgery. Patients randomized to RG were specifically required an angioCT. The images were exported 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 (Figure 1). Planned cases were available via cloud services for immediate use in the operating room (www.brainlab.com).
All surgeries were robot-assisted, conducted transperitoneally, and executed at Moinhos de Vento Hospital (Porto Alegre, Rio Grande do Sul), a tertiary center, from August 2022 to January 2024 by 8 urologists with experience in RAPN. AG was obtained through the Magic Leap 1 goggle (Magic Leap Inc., Plantation, FL, USA) (Figure 5); the only role Brainlab and Magic Leap industries had in this study was the providing of the software and the goggle free of charge.
Besides tumor and patient's baseline characteristics and intra-operative data, such as vessel clamping, ischemia time, estimated blood loss (EBL), use of hemostatic agents and excision technique, post-operative data, such as renal function, anatomopathology, complication rate and hospital staying, were also recorded. Our primary endpoint was ischemia time and the rest were secondary endpoints.
The results obtained were stored in a confidential database, with exclusive access to the researchers, and later organized in the Statistical Package for the Social Sciences (SPSS), proceeding to statistical analyzes.
Initially, descriptive analyzes were performed to characterize the sample of participants. Later, comparisons were made between GR and GC through non-parametric tests Mann-Whitney, Chi-square (CH2) and, when necessary, Fisher's exact test. These comparisons constituted homogeneity analyzes between the groups in the case of sociodemographic, preoperative and histopathological characteristics, while in the perioperative and functional variables they served to find a possible difference related to whether or not to use MIXREAL. For all analyzes performed, it was adopted the 95% confidence interval and the significance level of 5% (p ≤ .05).
The sample was calculated using the Risk Calc software. Assuming a difference in mean ischemia rate (primary outcome) between treatment groups to be 3.9 minutes (20), an expected population standard deviation to be 3.23 (11) and a clinically relevant difference to be of 1 minute (22), to achieve 80% power (i.e., 1-β=0.8) at the level of significance of 5% (α=0.05) with equal allocation (i.e., k=1) and dropout rate of 5%, a total sample of at least 34 patients, divided into two groups, would be required
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Realitatem Group | Experimental | Combination Product: Mixed Realityrobot assisted partial nephrectomy with use of mixed reality |
| Control group | No intervention | –robot assisted partial nephrectomy with out use of mixed reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients above 18 years old with solid renal masses or complex renal cysts Bosniak III/IV requiring partial nephrectomy
Key exclusion criteria (1 listed)
- solid renal masses or complex renal cysts Bosniak III/IV with initial indication of radical nephrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed RealityVirtual 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) | Combination product | Realitatem Group |
Primary outcome
ischemia time
Time frame: "Perioperative/Periprocedural"
time from renal artery clamping to its disclamping
8 secondary outcomes
total surgical time
Time frame: "Perioperative/Periprocedural"
conversion to open surgery
Time frame: "Perioperative/Periprocedural"
artery clamping
Time frame: "Perioperative/Periprocedural"
selective clamping
Time frame: "Perioperative/Periprocedural"
estimated blood loss
Time frame: "Perioperative/Periprocedural"
excision technique
Time frame: "Perioperative/Periprocedural"
conversion to radical nephrectomy
Time frame: "Perioperative/Periprocedural"
perioperative complication
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Results publication: PubMed 32456993Palumbo C, Pecoraro A, Knipper S, Rosiello G, Luzzago S, Deuker M, Tian Z, Shariat SF, Simeone C, Briganti A, Saad F, Berruti A, Antonelli A, Karakiewicz PI. Contemporary Age-adjusted Incidence and Mortality Rates of Renal Cell Carcinoma: Analysis According to Gender, Race, Stage, Grade, and Histology. Eur Urol Focus. 2021 May;7(3):644-652. doi: 10.1016/j.euf.2020.05.003. Epub 2020 May 23.
- Results publication: PubMed 36100483Bukavina L, Bensalah K, Bray F, Carlo M, Challacombe B, Karam JA, Kassouf W, Mitchell T, Montironi R, O'Brien T, Panebianco V, Scelo G, Shuch B, van Poppel H, Blosser CD, Psutka SP. Epidemiology of Renal Cell Carcinoma: 2022 Update. Eur Urol. 2022 Nov;82(5):529-542. doi: 10.1016/j.eururo.2022.08.019. Epub 2022 Sep 10.
- Results publication: PubMed 32886895Motzer RJ, Jonasch E, Boyle S, Carlo MI, Manley B, Agarwal N, Alva A, Beckermann K, Choueiri TK, Costello BA, Derweesh IH, Desai A, George S, Gore JL, Haas N, Hancock SL, Kyriakopoulos C, Lam ET, Lau C, Lewis B, Madoff DC, McCreery B, Michaelson MD, Mortazavi A, Nandagopal L, Pierorazio PM, Plimack ER, Ponsky L, Ramalingam S, Shuch B, Smith ZL, Somer B, Sosman J, Dwyer MA, Motter AD. NCCN Guidelines Insights: Kidney Cancer, Version 1.2021. J Natl Compr Canc Netw. 2020 Sep;18(9):1160-1170. doi: 10.6004/jnccn.2020.0043.
- Results publication: PubMed 32535076Wake N, Nussbaum JE, Elias MI, Nikas CV, Bjurlin MA. 3D Printing, Augmented Reality, and Virtual Reality for the Assessment and Management of Kidney and Prostate Cancer: A Systematic Review. Urology. 2020 Sep;143:20-32. doi: 10.1016/j.urology.2020.03.066. Epub 2020 Jun 12.
- Results publication: PubMed 28885161Detmer FJ, Hettig J, Schindele D, Schostak M, Hansen C. Virtual and Augmented Reality Systems for Renal Interventions: A Systematic Review. IEEE Rev Biomed Eng. 2017;10:78-94. doi: 10.1109/RBME.2017.2749527. Epub 2017 Sep 6.
- Results publication: PubMed 18366316Ukimura O, Gill IS. Imaging-assisted endoscopic surgery: Cleveland Clinic experience. J Endourol. 2008 Apr;22(4):803-10. doi: 10.1089/end.2007.9823.
- Results publication: PubMed 25577366Wang D, Zhang B, Yuan X, Zhang X, Liu C. Preoperative planning and real-time assisted navigation by three-dimensional individual digital model in partial nephrectomy with three-dimensional laparoscopic system. Int J Comput Assist Radiol Surg. 2015 Sep;10(9):1461-8. doi: 10.1007/s11548-015-1148-7. Epub 2015 Jan 11.
- Results publication: PubMed 31532520Shirk JD, Thiel DD, Wallen EM, Linehan JM, White WM, Badani KK, Porter JR. Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911598. doi: 10.1001/jamanetworkopen.2019.11598.
- Results publication: PubMed 31898992Porpiglia F, Checcucci E, Amparore D, Piramide F, Volpi G, Granato S, Verri P, Manfredi M, Bellin A, Piazzolla P, Autorino R, Morra I, Fiori C, Mottrie A. Three-dimensional Augmented Reality Robot-assisted Partial Nephrectomy in Case of Complex Tumours (PADUA >/=10): A New Intraoperative Tool Overcoming the Ultrasound Guidance. Eur Urol. 2020 Aug;78(2):229-238. doi: 10.1016/j.eururo.2019.11.024. Epub 2019 Dec 30.
- Results publication: PubMed 34591353Li L, Zeng X, Yang C, Un W, Hu Z. Three-dimensional (3D) reconstruction and navigation in robotic-assisted partial nephrectomy (RAPN) for renal masses in the solitary kidney: A comparative study. Int J Med Robot. 2022 Feb;18(1):e2337. doi: 10.1002/rcs.2337. Epub 2021 Oct 10.
- Results publication: PubMed 30912180Yoshida S, Sugimoto M, Fukuda S, Taniguchi N, Saito K, Fujii Y. Mixed reality computed tomography-based surgical planning for partial nephrectomy using a head-mounted holographic computer. Int J Urol. 2019 Jun;26(6):681-682. doi: 10.1111/iju.13954. Epub 2019 Mar 25. No abstract available.
- Results publication: PubMed 29487888Edgcumbe P, Singla R, Pratt P, Schneider C, Nguan C, Rohling R. Follow the light: projector-based augmented reality intracorporeal system for laparoscopic surgery. J Med Imaging (Bellingham). 2018 Apr;5(2):021216. doi: 10.1117/1.JMI.5.2.021216. Epub 2018 Feb 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Kives Berger, MSc study chair
Hospital Moinhos de Vento
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mixed Reality in people with Kidney Cancer, run by Hospital Moinhos de Vento at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemia time (time frame: "Perioperative/Periprocedural"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903260, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.