NCT05015179

Mixed Reality Technology in Laparoscopic Partial Nephrectomy

Completed NA Last updated 20 August 2021

What this trial tests

NA trial testing mixed reality technology in laparoscopic partial nephrectomy in Kidney Tumor in 47 participants. Completed in 1 March 2021.

Timeline

1 June 2020

Primary endpoint
1 February 2021

1 March 2021

Quick facts

Lead sponsor	St. Petersburg State Pavlov Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	47
Start date	1 June 2020
Primary completion	1 February 2021
Estimated completion	1 March 2021
Sites	1 location across Russia

Drugs / interventions tested

• mixed reality technology in laparoscopic partial nephrectomy

Conditions studied

• Kidney Tumor — all drugs for Kidney Tumor →

Sponsor

St. Petersburg State Pavlov Medical University

Who can join

18 and older, any sex, with Kidney Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.