## Protocol Section
### Identification Module
**NCT ID:** NCT05015179

**Brief Title:** Mixed Reality Technology in Laparoscopic Partial Nephrectomy

**Official Title:** Using Mixed Reality Technology to Facilitate Laparoscopic Partial Nephrectomy

#### Organization Study ID Info
**ID:** 38/124-25
#### Organization
**Class:** OTHER
**Full Name:** St. Petersburg State Pavlov Medical University
### Status Module
#### Completion Date
**Date:** 2021-03-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-08-20

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-06-01

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2021-08-20
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-07
**Study First Submit QC Date:** 2021-08-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Saint Petersburg State University, Russia

#### Lead Sponsor

**Class:** OTHER

**Name:** St. Petersburg State Pavlov Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Kidney Tumor

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 47

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Laparoscopic partial nephrectomy is performed with an intraoperative ultrasound (US) control

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Underwent Laparoscopic partial nephrectomy with the aid of the mixed reality model

**Intervention Names:**

- Procedure: mixed reality technology in laparoscopic partial nephrectomy

**Label:** Experimental

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental

**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

**Name:** mixed reality technology in laparoscopic partial nephrectomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** time required to expose renal pedicle during laparoscopic partial nephrectomy

**Time Frame:** during operation completion, min

**Measure:** time required to get from renal pedicle to tumor during laparoscopic partial nephrectomy

**Time Frame:** during operation completion, min

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Saint Petersburg

**Country:** Russian Federation

**Facility:** Saint Petersburg State University Hospital

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10703

- Name: Kidney Neoplasms

- Relevance: HIGH

- As Found: Kidney tumors

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007680

- Term: Kidney Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
