Clinical trial assessing the safety and feasibility of robotic urological procedures using the Toumai robot (SAFTOUro)
Clinical trial assessing the safety and feasibility of robotic urological procedures using the Toumai robot (SAFTOUro) for patients undergoing surgery for urological (prostate or renal) cancers
Sydney Local Health District
30 participants
Mar 23, 2026
Interventional
Conditions
Summary
Brief description of the study purpose This study aims to find out whether prostate and kidney cancer surgery can be performed safely and reliably using a newer robotic surgical system called the Toumai® MT-1000. Surgeons already perform these procedures using other robotic platforms, but the Toumai system is new to Australia, so it needs to be carefully evaluated in real clinical settings. Who is it for? You may be eligible for this study if you are aged 18 years or older and are scheduled to have prostate cancer surgery (radical prostatectomy) or kidney cancer surgery (partial nephrectomy or nephroureterectomy) at Concord Repatriation General Hospital. You must be considered suitable for robotic surgery by your treating surgeon, able to understand the study information, and able to provide written consent. Only patients having an elective (non-emergency) operation are eligible. Study details Participants will undergo prostate or kidney cancer surgery assisted by the Toumai® MT 1000 robotic surgical system. The surgery itself is the same type of operation they would receive as part of standard care; the difference is that the surgeon uses a newer robotic platform to assist during the procedure. Following surgery, participants will be monitored as part of routine clinical care and will be followed in the months after their operation to assess recovery. This includes monitoring safety outcomes and collecting information on symptoms, quality of life, and functional recovery. The aim is to find out whether this new robot allows surgeries to be completed safely without needing to convert to an open operation, and whether recovery is similar to patients who have had surgery using other robotic systems.
Eligibility
Inclusion Criteria1
- Participants can take part in the study if they are adults aged 18 years or older and are scheduled to have prostate cancer surgery (radical prostatectomy) or kidney cancer surgery (partial nephrectomy or nephroureterectomy) at Concord Repatriation General Hospital. They must be considered suitable for robotic surgery by their treating surgeon and be able to understand the study information and provide written consent. Only patients booked for an elective (non-emergency) operation are eligible.
Exclusion Criteria1
- People cannot take part in the study if they are unable to give informed consent or if their cancer or overall health makes robotic surgery unsafe. Patients will also be excluded if specific medical or tumour features mean that a robotic approach is not suitable. For kidney cancer surgery, people will be excluded if they have only one functioning kidney, very complex kidney tumours, evidence of cancer that has spread, severe kidney disease requiring dialysis, medical conditions that prevent the use of contrast imaging, or bleeding or clotting problems. Patients having emergency surgery or who do not meet the clinical requirements for robotic surgery will not be eligible to participate.
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Interventions
The intervention in this study is the use of the Toumai® MT-1000 robotic surgical system to assist surgeons performing prostate or kidney cancer operations. The Toumai® MT-1000 is a next-generation robotic platform developed by Shanghai MicroPort MedBot and is designed to improve precision, instrument control, and visualisation during minimally invasive surgery. It provides a highly magnified 3D view and wrist-like robotic instruments that allow the surgeon to operate through small incisions while remaining in full control at all times. The Toumai® MT-1000 received approval from the Therapeutic Goods Administration (TGA) in May 2025 and is listed on the Australian Register of Therapeutic Goods (ARTG ID 487874) for use in urological, general, thoracic and gynaecological endoscopic surgery. In this study, the type of surgery performed is the same as standard care; the study is evaluating the performance and safety of this newer robotic platform rather than introducing a different procedure. These operations typically take between two and four hours. All surgeons complete Toumai-specific training, including an online learning module, two hours of supervised dry-lab training, and at least five proctored cases led by an accredited national proctor before operating independently. The study will observe how well the robotic system performs in real clinical settings by monitoring safety, and how patients recover after surgery, including their symptoms, quality of life and function in the months after their operation. Adherence to the intervention is monitored through review of medical records and peri-operative data forms completed after each operation, documenting use of the system, any technical issues, and whether the procedure followed the approved protocol.
Locations(1)
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ACTRN12626000438358