Supervised robotic kidney stone removal with flexible ureteroscopy
Official title: A Feasibility Trial of a Novel Robotic System for Retrograde Intrarenal Surgery
Run by Chinese University of Hong Kong · NCT07411391 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | cart |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Status | Recruiting |
| Started | February 15, 2026 |
| Main results expected | August 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07411391 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Prince of Wales Hospital
Hong Kong, Hong Kong Recruiting -
North District Hospital
Sheung Shui, Hong Kong Recruiting
Study contacts
- Study coordinator: Alex Qinyang Liu, MBBS, MSc, FRCSEd
- Email: alexliu@surgery.cuhk.edu.hk
- Phone: 852+35052625
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.