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Mixed Reality Technology in Laparoscopic Partial Nephrectomy

Using Mixed Reality Technology to Facilitate Laparoscopic Partial Nephrectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05015179
Enrollment
47
Registered
2021-08-20
Start date
2020-06-01
Completion date
2021-03-01
Last updated
2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Tumor

Brief summary

The aim of our study was: a) to evaluate the usefulness of the MR model for renal pedicle exposure and identification of the tumor's exact location during LPN, and b) to evaluate the subjective utility of the MR model as an intraoperative reference tool. Investigators prospectively enrolled 47 patients with LPN between June 2020 and February 2021. Patients were randomly assigned into two groups: the control group (24 patients), who underwent operation with an intraoperative ultrasound (US) control and the experimental group (23 patients), who underwent operation with the aid of the MR model. Randomization was performed using a computerized randomization program and sealed envelopes. Patients were included in the study if they were 18 years of age or older, were able to sign informed consent, and had T1a renal tumors amenable to LPN. Patients were excluded if they were unwilling to participate or did not meet the inclusion criteria. For each patient, investigators prospectively collected demographic data including age, body mass index, clinical tumor size, side, location, and complexity score according to the PADUA scoring system; perioperative data (including time for renal pedicle exposure and time for renal tumor detection and duration of ischemia); pathological data; data on postoperative functional outcome and complications, classified according to the Clavien-Dindo system.

Interventions

PROCEDUREmixed reality technology in laparoscopic partial nephrectomy

All patients undergo contrast-enhanced computed tomography before surgery. DICOM files are converted to a 3D model. This model is then sent to HoloLens 2 smart glasses using HLOIA software

Sponsors

Saint Petersburg State University, Russia
CollaboratorOTHER
St. Petersburg State Pavlov Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* able to sign informed consent * had T1a renal tumors amenable to LPN

Exclusion criteria

* were unwilling to participate * did not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
time required to expose renal pedicle during laparoscopic partial nephrectomyduring operation completion, min
time required to get from renal pedicle to tumor during laparoscopic partial nephrectomyduring operation completion, min

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026