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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | ID 1052 |
| Sponsor | Clínica Alemana |
| Funder | Clínica Alemana de Santiago |
- 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
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
Public, Scientific, Principal investigator
Avda. Manquehue Norte 1410
Piso 12
Vitacura
Región Metropolitana
Santiago
7650568
Chile
 ORCID ID |
0000-0003-4952-2283 |
|---|---|
| Phone | +56 (0)2 2210 1111 |
| hotaola@alemana.cl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective single-center case series |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| Scientific title | Introducing the Toumai™ System for robot-assisted radical prostatectomy: a prospective feasibility and safety study in a tertiary care center (TouRARP) |
| Study acronym | TouRARP |
| Study objectives | Assess 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) studied | Prostate cancer |
| Intervention | Robot-assisted radical prostatectomy with Toumai™ robotic system |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Toumai™ robotic system (MT 1000) |
| Primary outcome measure(s) |
1. Feasibility, defined as the successful completion of surgical procedures without needing to convert to conventional techniques at the end of surgery |
| Key secondary outcome measure(s) |
Perioperative variables associated with this new robotic platform, measured using the Clavien-Dindo classification at 1 month of follow-up |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | Localized prostate cancer |
| Key exclusion criteria | Patients for whom all perioperative information was not available were excluded from the analysis |
| Date of first enrolment | 04/12/2024 |
| Date of final enrolment | 28/08/2025 |
Locations
Countries of recruitment
- Chile
Study participating centre
Vitacura
Región Metropolitana
Santiago
7650568
Chile
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Datasets generated during de current study will be available upon request from Hugo Otaola-Arca (hugotaolarca@hotmail.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/09/2025: Study's existence confirmed by the Clínica Alemana.
