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OpenTrials
Completed

NCT Number: NCT05015179

Mixed Reality Technology in Laparoscopic Partial Nephrectomy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mixed reality technology in laparoscopic partial nephrectomy

Procedure

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

Primary outcomes

  1. time required to expose renal pedicle during laparoscopic partial nephrectomy

    Time frame: during operation completion, min

  2. time required to get from renal pedicle to tumor during laparoscopic partial nephrectomy

    Time frame: during operation completion, min

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Collaborators

  • Saint Petersburg State University, Russia

Registry information

Official study title

Using Mixed Reality Technology to Facilitate Laparoscopic Partial Nephrectomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2021
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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