Supervised Endoscopic Tele-controlled Intelligent Lithotripsy (SENTINEL-1)

A Feasibility Trial of a Novel Robotic System for Retrograde Intrarenal Surgery

This is a phase I feasibility study to investigate the use of a novel intelligent robotic retrograde intrarenal surgery (RIRS) platform. The TaloStone T1000 RIRS system can manipulate the flexible ureteroscope, with remote control of the instruments (laser fibre or basket) and ureteral access sheath movements. Beyond teleoperation, the TaloStone T1000 RIRS system integrates AI perception models and decision-making algorithms to enable the supervised autonomous execution of critical tasks within the RIRS workflow.

Study Overview

• Status: Recruiting
• Conditions: Renal Stone
• Intervention / Treatment: Procedure: RIRS using the TaloStone T1000 RIRS platform

Detailed Description

I. Introduction

Retrograde intrarenal surgery (RIRS) has become a preferred method for the diagnosis and treatment of urological diseases, such as kidney stone removal. However, the complex urinary and limited visibility of existing endoscope lead to inefficient manipulation of flexible ureteroscopes. Besides, conventional flexible ureteroscopy requires repetitive manual manipulation, which often results in surgeon fatigue, mucosa injury from respiratory motion, and variable stone clearance rates, particularly in complex calyceal anatomies.

The research focuses on the development of an novel robotic system for RIRS, currently dubbed "TaloStone T1000". The robotic system platform consists of a surgeon control console, a multi-functional video cart, and patient-side robotic arm with fiber-optic-sensitized flexible ureteroscopy as shown in Fig. 1. The surgeon console with optimized design of ergonomics is equipped with haptic master devices for smooth and precise control of the robotic arm to manipulate the flexible ureteroscope as well as instruments, e.g., stone baskets and laser fibers. The system also supports seamless integration of multiple modalities, including pre-operative CT scans, intra-operative endoscopic videos, and fiber-optic sensing. Besides, the self-developed flexible ureteroscope is embedded with fiber optic sensors for real-time shape sensing, force estimation, and simultaneous intrarenal pressure control and temperature monitoring. Shape sensing enables precise navigation of the ureteroscope within the renal collecting system, and force estimation provides accurate feedback of tip contact interaction to the master devices on the surgeon control.

Moreover, AI algorithms are incorporated to assist in diagnostics and higher level of supervised surgical autonomy, thereby improving safety and efficiency. The investigators developed AI-powered diagnostics for stone sensing, laser fiber recognition, depth awareness, and CT-to-endoscopy localization. Based on the sensing results from AI-powered diagnostics, the investigators proposed a supervised framework that can automate repetitive procedures throughout in-sheath and ureter navigation, laser approaching, and laser trajectory planning. The entire operation is under supervision of the surgeon, who can use one trigger on the master device or footswitch to enable or disable the supervised automated features. The foot pedal of laser device remains to trigger laser emission by the surgeon for stone fragmentation, dusting, and pop-corning. The basic safety and essential performance of both hardware and software in the robotic system were developed under clinical standards and medical device regulations.

To date, a total of three cadaveric studies have been conducted using the robotic system. In August 2024, the investigators performed the first cadaver study of the robotic system at Prince of Wales Hospital (PWH), where user study of ergonomic manners and tele-operation control of stone treatment was investigated. The second and third cadaver studies, focusing on the AI-powered features of the robotic system, were completed at PWH in June and December 2025. Synthetic renal stones of around 3mm were retrogradely inserted to the renal collecting systems, with successful fragmentation via the robotic RIRS system using Holmium:YAG laser. Over 10 doctors from PWH and the Chinese University of Hong Kong, participated in the cadaver studies. The current system response, motion speed of the robotic system, and operations with ergonomic control console can satisfy the requirements of the doctors. In addition to the cadaver studies, the investigators have conducted a set of laboratory testing and experiments, validating its robustness and stability of the system.

Subsequent to successful cadaveric experiments, the investigators planned to further validate of the feasibility of the use of the system in clinical cases. In this study, the investigators aim to evaluate the robotic system's safety and feasibility in RIRS in a stage 1, proof of concept study that follows the concepts outlined in the IDEAL framework (Idea, Development, Exploration, Assessment, Long-term Study).

II. Methods

Aim

The aim of this study is to evaluate the feasibility and safety of performing RIRS using the TaloStone T1000 system.

Study Design

This is a prospective, single-arm study that will be conducted by investigators from The Chinese University of Hong Kong/Prince of Wales Hospital in the period from November 2025 to June 2026. The investigators are experts in endo-urological surgery and robot-assisted surgery. The study design follows the guidelines for stage 1 of the IDEAL framework. The study will be carried out in accordance with the Declaration of Helsinki of the World Medical Association and the International Conference on Harmonization - Good Clinical Practice.

The study information will be provided to subjects during a preoperative consultation by the investigators and the research staff. Subjects will be provided with approved informed consent explaining the study procedure, risks, assessments, and required compliance; and will be given ample time to make their decision regarding participation in the study.

Perioperative data and outcomes from all cases of those participating in the study will be reviewed by an independent Data and Safety Monitoring Committee (consisting two senior urologists not involved in this study) for safety and identification of serious perioperative complications (within 30 days after the surgery) as interim to safeguard study subjects. The Committee will make periodic recommendations to the study team on whether to continue, modify, or prematurely terminate the study. Any adverse events will also be immediately reported to the Clinical Research Ethics Committee of the hospital.

Reporting of this stage 1 study will follow the IDEAL Reporting Guidelines.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Qinyang Liu, MBBS, MSc, FRCSEd; Phone Number: 852+35052625; Email: alexliu@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Chi Fai Ng, MBChB, MD, FRCSEd; Phone Number: 852+35052625; Email: ngcf@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Alex Qinyang Liu, MBBS, MSc, FRCSEd; Phone Number: 852+35052625; Email: alexliu@surgery.cuhk.edu.hk
    • Contact: Chi Fai Ng, MBChB, MD, FRCSEd; Phone Number: 852+35052625; Email: ngcf@surgery.cuhk.edu.hk
    • Sub-Investigator: Steffi Kar Kei Yuen, MBBS, FRCSEd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: RIRS arm; Use of the TaloStone T1000 RIRS system

Procedure: RIRS using the TaloStone T1000 RIRS platform; Retrograde intrarenal surgery (RIRS) will be performed using the TaloStone T1000 RIRS system. Beyond teleoperation, the TaloStone T1000 RIRS system integrates advanced AI perception models and decision-making algorithms to enable the autonomous execution of critical tasks within the RIRS workflow. The AI-based vision models coupled with sensors in the fURS allow real-time scene understanding, depth perception, stone size estimation, pressure and temperature feedback, and object tracking - thus establishing a robust foundation for higher level of surgical autonomy. Under supervision by the surgeon, the TaloStone T1000 RIRS system can perform supervised navigation into the collecting system, actively track a target stone, dynamically target the laser fibre tip towards a stone, plan the laser fragmentation route, and perform scope withdrawal for stone suction with re-entry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	Successful RIRS by the robotic system, i.e. without conversion to conventional manual RIRS	Intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	by non-contrast computer tomography (NCCT) performed within 1 month of surgery; without residual stone fragments, or residual stone fragments <2mm	Within post-operative 1 month
Operative time	total operative time (time from start of operation to the end of operation); console time (from start of control of robotic system to end of control of robotic system); robotic control time (defined as time spent manipulating the control for navigation); robotic set-up time (from the moment the robot is pushed into the operating room to the moment the flexible ureteroscope is attached to the robot); procedure time (total operative time - The robot set-up time); lasing time	Intra-operative
Total laser energy used	Laser energy in terms of kJ	Intra-operative
Total radiation dose during operation	Radiation dose based on fluoroscopy readings	Intra-operative
Surgeon radiation exposure	- by radiation dosimeter	Intra-operative
Length of hospital stay	- days of stay as in-patient	During admission period (up to 30 days)
Post-operative pain	- by visual analogue scale, from 0-10 with 10 being the most pain	From immediately post-operatively to discharge (day 0 to day 1)
Post-operative complications	By "Clavien-Dindo Classification"	Within post-operative 30 days
Surgeon questionnaires	Completed the Subjective Mental Effort Questionnaire (SMEQ) to assess subjective during RIRS surgery.	Immediately post-operative, day 0
Surgeon questionnaires	Completed the System Usability Scale (SUS) questionnaire to assess the subjective usability of the robotic system during RIRS surgery. The questionnaire uses a 1-5 scale, where 1 = Strongly disagree and 5 = Strongly agree.	Immediately post-operative, day 0
Surgeon questionnaires	Completed the NASA Task Load Index (NASA-TLX) questionnaire to assess subjective mental and physical demand during RIRS surgery. The questionnaire uses a 1-10 scale, where 1 = Very Low and 10 = Very High.	Immediately post-operative, day 0
Surgeon questionnaires	Completed the Simulator Sickness Questionnaire (SSQ) to assess the subjective symptoms experienced during or after RIRS surgery. The questionnaire uses a 0-3 scale, where 0 = None, 1 = Slight, 2 = Moderate, 3 = Severe	Immediately post-operative, day 0
Surgeon questionnaires	Completed the Likert Scales on Ergonomics and Comfort questionnaire, which assessed the subjective experience of minimal discomfort or fatigue during RIRS surgery. The questionnaire uses a 1-5 scale, where 1 = Strongly disagree and 5 = Strongly agree.	Immediately post-operative, day 0

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

General Publications

• Lu, Y., Chen, W., Lu, B., Zhou, J., Chen, Z., Dou, Q. and Liu, Y.H., 2024. Adaptive online learning and robust 3-d shape servoing of continuum and soft robots in unstructured environments. Soft Robotics, 11(2), pp.320-337.
• Kuntz, A., Emerson, M., Ertop, T.E., Fried, I., Fu, M., Hoelscher, J., Rox, M., Akulian, J., Gillaspie, E.A., Lee, Y.Z. and Maldonado, F., 2023. Autonomous medical needle steering in vivo. Science Robotics, 8(82), p.eadf7614.
• Wei, R., Guo, J., Lu, Y., Zhong, F., Liu, Y., Sun, D. and Dou, Q., 2024. Scale-aware monocular reconstruction via robot kinematics and visual data in neural radiance fields. Artificial Intelligence Surgery, 4(3), pp.187-198.
• Ross T, Reinke A, Full PM, Wagner M, Kenngott H, Apitz M, Hempe H, Mindroc-Filimon D, Scholz P, Tran TN, Bruno P, Arbelaez P, Bian GB, Bodenstedt S, Bolmgren JL, Bravo-Sanchez L, Chen HB, Gonzalez C, Guo D, Halvorsen P, Heng PA, Hosgor E, Hou ZG, Isensee F, Jha D, Jiang T, Jin Y, Kirtac K, Kletz S, Leger S, Li Z, Maier-Hein KH, Ni ZL, Riegler MA, Schoeffmann K, Shi R, Speidel S, Stenzel M, Twick I, Wang G, Wang J, Wang L, Wang L, Zhang Y, Zhou YJ, Zhu L, Wiesenfarth M, Kopp-Schneider A, Muller-Stich BP, Maier-Hein L. Comparative validation of multi-instance instrument segmentation in endoscopy: Results of the ROBUST-MIS 2019 challenge. Med Image Anal. 2021 May;70:101920. doi: 10.1016/j.media.2020.101920. Epub 2020 Nov 28.
• Dupont, P.E. and Degirmenci, A., 2025. The grand challenges of learning medical robot autonomy. Science Robotics, 10(104), p.eadz8279.
• Long, Y., Lin, A., Kwok, D.H.C., Zhang, L., Yang, Z., Shi, K., Song, L., Fu, J., Lin, H., Wei, W. and Chen, K., 2025. Surgical embodied intelligence for generalized task autonomy in laparoscopic robot-assisted surgery. Science Robotics, 10(104), p.eadt3093.
• Lu, Y., Chen, W., Li, B., Lu, B., Zhou, J., Chen, Z. and Liu, Y.H., 2023. A robust graph-based framework for 3-d shape reconstruction of flexible medical instruments using multi-core fbgs. IEEE Transactions on Medical Robotics and Bionics, 5(3), pp.472-485.
• Lu, Y., Lu, B., Li, B., Guo, H. and Liu, Y.H., 2021. Robust three-dimensional shape sensing for flexible endoscopic surgery using multi-core FBG sensors. IEEE Robotics and Automation Letters, 6(3), pp.4835-4842.
• Chen, W., Lu, Y., Li, B., Zhou, J., Cao, H., Chen, F. and Liu, Y.H., 2024, June. Intuitive teleoperation control for flexible robotic endoscopes under unkonwn environmental interferences. In 2024 IEEE 18th International Conference on Control & Automation (ICCA) (pp. 24-29). IEEE.
• Schlenk C, Hagmann K, Steidle F, Oliva Maza L, Kolb A, Hellings-Kuss A, Schob DS, Klodmann J, Miernik A, Albu-Schaffer A. A robotic system for solo surgery in flexible ureteroscopy: development and evaluation with clinical users. Int J Comput Assist Radiol Surg. 2023 Sep;18(9):1559-1569. doi: 10.1007/s11548-023-02883-5. Epub 2023 Apr 9.
• Giusti G, Proietti S, Villa L, Cloutier J, Rosso M, Gadda GM, Doizi S, Suardi N, Montorsi F, Gaboardi F, Traxer O. Current Standard Technique for Modern Flexible Ureteroscopy: Tips and Tricks. Eur Urol. 2016 Jul;70(1):188-194. doi: 10.1016/j.eururo.2016.03.035. Epub 2016 Apr 14.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Urolithiasis; RIRS; Renal stone; Flexible URS; Supervised autonomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Nephrolithiasis; Urolithiasis
• Other Study ID Numbers: CRE-2025.665 (Other Identifier: The Joint CUHK-NTEC CREC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code will be available.
• IPD Sharing Time Frame: It will be available after the publication of the manuscript (latest 31 Dec 2027 by estimation), and will be available for up to 5 years afterwards
• IPD Sharing Access Criteria: IPD will be shared in a de-identified manner for reasonable studies with approved from the relevant institutional review board.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No