Mixed Reality Technology in Laparoscopic Partial Nephrectomy
Primary Purpose
Kidney Tumor
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
mixed reality technology in laparoscopic partial nephrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Tumor
Eligibility Criteria
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
Sites / Locations
- Saint Petersburg State University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Experimental
Arm Description
Laparoscopic partial nephrectomy is performed with an intraoperative ultrasound (US) control
Underwent Laparoscopic partial nephrectomy with the aid of the mixed reality model
Outcomes
Primary Outcome Measures
time required to expose renal pedicle during laparoscopic partial nephrectomy
time required to get from renal pedicle to tumor during laparoscopic partial nephrectomy
Secondary Outcome Measures
Full Information
NCT ID
NCT05015179
First Posted
August 7, 2021
Last Updated
August 14, 2021
Sponsor
St. Petersburg State Pavlov Medical University
Collaborators
Saint Petersburg State University, Russia
1. Study Identification
Unique Protocol Identification Number
NCT05015179
Brief Title
Mixed Reality Technology in Laparoscopic Partial Nephrectomy
Official Title
Using Mixed Reality Technology to Facilitate Laparoscopic Partial Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg State Pavlov Medical University
Collaborators
Saint Petersburg State University, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Laparoscopic partial nephrectomy is performed with an intraoperative ultrasound (US) control
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Underwent Laparoscopic partial nephrectomy with the aid of the mixed reality model
Intervention Type
Procedure
Intervention Name(s)
mixed reality technology in laparoscopic partial nephrectomy
Intervention Description
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 Outcome Measure Information:
Title
time required to expose renal pedicle during laparoscopic partial nephrectomy
Time Frame
during operation completion, min
Title
time required to get from renal pedicle to tumor during laparoscopic partial nephrectomy
Time Frame
during operation completion, min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Saint Petersburg State University Hospital
City
Saint Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mixed Reality Technology in Laparoscopic Partial Nephrectomy
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