Prospective feasibility and safety study of robotic-assisted radical prostatectomy with the new Toumai™ robotic system

ISRCTN ISRCTN16977044
DOI https://doi.org/10.1186/ISRCTN16977044
Secondary identifying numbers ID 1052
Submission date
28/08/2025
Registration date
01/09/2025
Last edited
01/09/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Transitioning to a new robotic platform presents regulatory, logistical, and financial challenges. The Toumai™ (MicroPort® MedBot™) system has received European CE mark approval for urology, yet clinical experience outside China is limited. This study aims to assess the feasibility and safety of robot-assisted radical prostatectomy (RARP) using the Toumai™ robotic system in a tertiary center.

Who can participate?
Patients aged 18 years and over with localized prostate cancer who want to be treated with robotic radical prostatectomy

What does the study involve?
Patients are treated with robot-assisted radical prostatectomy using the Toumai™ MT1000 platform.

What are the possible benefits and risks of participating?
Prostate cancer surgery carries specific risks but participating in the study does not increase those risks as it is a validated technology with CE mark approval.

Where is the study run from?
Clinica Alemana de Santiago (Chile)

When is the study starting and how long is it expected to run for?
December 2024 to August 2025

Who is funding the study?
Clínica Alemana de Santiago (Chile)

Who is the main contact?
Hugo Otaola, Hugotaolarca@hotmail.com

Contact information

Dr Hugo Otaola Arca
Public, Scientific, Principal Investigator

Avda. Manquehue Norte 1410
Piso 12
Vitacura
Región Metropolitana
Santiago
7650568
Chile

ORCiD logoORCID ID 0000-0003-4952-2283
Phone +56 (0)2 2210 1111
Email hotaola@alemana.cl

Study information

Study designProspective single-center case series
Primary study designObservational
Secondary study designCase series
Study setting(s)Hospital
Study typeTreatment
Scientific titleIntroducing the Toumai™ System for robot-assisted radical prostatectomy: a prospective feasibility and safety study in a tertiary care center (TouRARP)
Study acronymTouRARP
Study objectivesAssess the feasibility and safety of robot-assisted radical prostatectomy (RARP) using the Toumai™ robotic system in a tertiary center. Furthermore, the researchers aimed to describe its key features to guide centers considering this technology
Ethics approval(s)Ethics approval not required
Health condition(s) or problem(s) studiedProstate cancer
InterventionRobot-assisted radical prostatectomy with Toumai™ robotic system
Intervention typeDevice
Pharmaceutical study type(s)Not Applicable
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Toumai™ robotic system (MT 1000)
Primary outcome measure1. Feasibility, defined as the successful completion of surgical procedures without needing to convert to conventional techniques at the end of surgery
2. Safety evaluated through documentation of intraoperative or postoperative complications at 1 month of follow-up
Secondary outcome measuresPerioperative variables associated with this new robotic platform, measured using the Clavien-Dindo classification at 1 month of follow-up
Overall study start date01/12/2024
Completion date31/08/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants50
Total final enrolment50
Key inclusion criteriaLocalized prostate cancer
Key exclusion criteriaPatients for whom all perioperative information was not available were excluded from the analysis
Date of first enrolment04/12/2024
Date of final enrolment28/08/2025

Locations

Countries of recruitment

  • Chile

Study participating centre

Clínica Alemana
Av. Manquehue Nte. 1410
Vitacura
Región Metropolitana
Santiago
7650568
Chile

Sponsor information

Clínica Alemana
Hospital/treatment centre

Avda. Manquehue Norte 1410
Piso 12
Vitacura
Región Metropolitana
Santiago
7650568
Chile

Website https://www.clinicaalemana.cl/
ROR logo "ROR" https://ror.org/028ynny55

Funders

Funder type

Hospital/treatment centre

Clínica Alemana de Santiago
Private sector organisation / Other non-profit organizations
Alternative name(s)
Clínica Alemana
Location
Spain

Results and Publications

Intention to publish date01/09/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer -reviewed journal
IPD sharing planDatasets generated during de current study will be available upon request from Hugo Otaola-Arca (hugotaolarca@hotmail.com)

Editorial Notes

01/09/2025: Study's existence confirmed by the Clínica Alemana.