NCT06290427

Brief Summary

The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms:

  • DaVinci®;
  • Hugo®. The questions it aims to answer are: Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable? Participants will be invited to join one of these two experimental group:
  • surgery with the DaVinci platform;
  • surgery with the Hugo platform.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

February 21, 2024

Last Update Submit

January 2, 2025

Conditions

Renal Carcinoma

Keywords

Robotic-assisted surgeryPartial NephrectomyMultiple surgical platformsPostoperative complicationsOperative outcomes

Outcome Measures

Primary Outcomes (3)

  • Number of participants with postoperative complications

    Overall postoperative complications (% score \>0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Over the 4 days post surgery

  • Number of participants with moderate to major postoperative complications

    Moderate to major complications (% score \>=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Over the 4 days post surgery

  • Number of participants with major postoperative complications

    Major complications (% score \>=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Over the 4 days post surgery

Secondary Outcomes (13)

  • Overall duration of the surgery

    Intraoperative

  • Number of intraoperative complications

    Intraoperative

  • Type of intraoperative complications

    Intraoperative

  • Number of intraoperative technical malfunctions

    Intraoperative

  • Type of intraoperative technical malfunctions

    Intraoperative

  • +8 more secondary outcomes

Study Arms (2)

DaVinci system

ACTIVE COMPARATOR

Robot-assisted partial nephrectomy is performed using the DaVinci platform

Device: DaVinci RAPN

Hugo RAS system

EXPERIMENTAL

Robot-assisted partial nephrectomy is performed using the Hugo RAS platform

Device: Hugo RAS RAPN

Interventions

DaVinci RAPNDEVICE

Robot-assisted Partial Nephrectomy with DaVinci® Surgical System

DaVinci system
Hugo RAS RAPNDEVICE

Robot-assisted Partial Nephrectomy with Hugo™ RAS System

Hugo RAS system

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient aged between 18 and 90 years old;
  • patient with localized kidney tumor suitable for partial nephrectomy;
  • patient able to understand and sign the informed consent;
  • patient compliance with the follow-up program.

You may not qualify if:

  • patient not suitable for partial nephrectomy;
  • patient unable to understand and sign the informed consent;
  • patient unable to follow the monitoring program;
  • patient refusal to participate to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Unit, AOUI Verona

Verona, VR, 37126, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal CellPostoperative Complications

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alessandro AA Antonelli, MD

    Azienda Ospedaliera Universitaria Integrata Verona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro AA Antonelli, MD

CONTACT

+39 0458127701alessandro.antonelli@aovr.veneto.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Director of Urology Unit

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 4, 2024

Study Start

February 1, 2024

Primary Completion

December 12, 2024

Study Completion

June 1, 2025

Last Updated

January 3, 2025

Record last verified: 2025-01

Locations

IT(1)