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Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

NCT06059859 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2025-08-12

No results posted yet for this study

Summary

Accurate preservation of neuro-vascular bundles is crucial in guaranteeing erectile function recovery after robot assisted radical prostatectomy (RARP). However, the nerve sparing approach is associated with higher rates of positive surgical margins (PSM) at final pathology. Augmented reality (AR) RARP was previously associated with a 10-15% reduction in the rates of PSMs in two retrospective series. However, prospective studies are needed to demonstrate clinical utility and to validate these technologies. The hypotheses of this study are that: 1) AR RARP reduces the rates of PSMs, if compared to standard approach; 2) AR RARP can guarantee a more accurate preservation of neurovascular bundles and, in consequence, a greater recovery of erectile function; 3) the lower rates of PSMs will translate in greater oncological control of the disease.

Conditions

  • Prostatic Neoplasm

Interventions

PROCEDURE

Augmented reality robot-assited radical prostatectomy

Robot assisted radical prostatectomy using the Da Vinci surgical robot system (XI model; Intuitive Surgical, Sunnyvale, Calif) and a port device (Alexis; Applied Medical, Rancho Santa Margarita, Calif) system for prostate extraction. Virtual image of the prostate will be overlapped onto the endoscopic view of the Da Vinci surgical robot system using the TilePro system.

DEVICE

Mixed reality intraoperative frozen section analysis

Microsoft Hololens head-mounted display system will be used for inking prostate margins during intraoperative frozen section analysis

PROCEDURE

Robot-assited radical prostatectomy

Robot assisted radical prostatectomy using the Da Vinci surgical robot system (XI model; Intuitive Surgical, Sunnyvale, Calif) and a port device (Alexis; Applied Medical, Rancho Santa Margarita, Calif) system for prostate extraction.

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Ottavio de Cobelli, MD; PhD · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059859 on ClinicalTrials.gov