Mixed Reality Technology in Laparoscopic Partial Nephrectomy

Kidney Tumor Clinical Trial

Official title:

Using Mixed Reality Technology to Facilitate Laparoscopic Partial Nephrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015179
• Other study ID #: 38/124-25
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: August 2021
• Source: St. Petersburg State Pavlov Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Kidney Tumor

Intervention

Procedure:
• mixed 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

Locations

Country	Name	City	State
Russian Federation	Saint Petersburg State University Hospital	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University	Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time required to expose renal pedicle during laparoscopic partial nephrectomy		during operation completion, min
Primary	time required to get from renal pedicle to tumor during laparoscopic partial nephrectomy		during operation completion, min