Supervised robotic kidney stone removal with flexible ureteroscopy
A Feasibility Trial of a Novel Robotic System for Retrograde Intrarenal Surgery
This study will test a new robotic system that lets surgeons remotely and semi-autonomously remove kidney stones during flexible ureteroscopy in adults with stones up to 2 cm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | cart |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07411391 on ClinicalTrials.gov |
What this trial studies
This is a Phase I feasibility study of the TaloStone T1000, a robotic RIRS platform that combines a surgeon console, a patient-side robotic arm, and AI perception and decision-making models to enable supervised autonomous execution of key steps. The system uses a fiber-optic-sensitized flexible ureteroscope with real-time shape sensing, force estimation, intrarenal pressure control, and temperature monitoring, and supports remote control of laser fibers, baskets, and an access sheath. Adult patients indicated for RIRS with renal stones up to 2 cm will undergo procedures at a single center using the platform, with primary focus on safety, technical feasibility, and measures such as stone clearance, mucosal injury, and intraoperative parameters. The platform integrates preoperative CT and intraoperative video to guide semi-autonomous task execution under surgeon supervision.
Who should consider this trial
Good fit: Adults over 18 with renal stones up to 2 cm who are clinically scheduled for flexible ureteroscopy (RIRS) and can give informed consent are the intended candidates.
Not a fit: Patients with larger stones (>2 cm), untreated active infection, uncorrected coagulopathy, other active malignancy, pregnancy, or other contraindications to RIRS would not be expected to benefit or be eligible.
Why it matters
Potential benefit: If successful, the system could improve precision and consistency of ureteroscopic stone removal while reducing surgeon fatigue and procedure-related mucosal injury.
How similar studies have performed: Robotic assistance for endourology has been explored, but supervised autonomous execution of RIRS tasks with integrated AI is largely novel and not yet proven in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Adult patients \>18 years old 2. Renal stone(s) less than 1cm 2cm in maximal length 3. Clinically indicated for RIRS 4. Willingness to participate as demonstrated by giving informed consent Exclusion criteria 1. Patients with no preoperative CT imaging available 2. Patients who are not recommended to receive RIRS 3. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention 4. Untreated active infection 5. Un-corrected coagulopathy 6. Presence of another malignancy or distant metastasis 7. Emergency surgery 8. Vulnerable population (e.g. mentally disabled, pregnant)
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Alex Qinyang Liu, MBBS, MSc, FRCSEd
- Email: alexliu@surgery.cuhk.edu.hk
- Phone: 852+35052625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.