Health TrialsbyHealthPanel

Supervised Endoscopic Tele-controlled Intelligent Lithotripsy

ConditionRenal Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients >18 years old

Renal stone(s) less than 1cm 2cm in maximal length

Clinically indicated for RIRS

Willingness to participate as demonstrated by giving informed consent

Disqualifiers

Patients with no preoperative CT imaging available

Patients who are not recommended to receive RIRS

Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention

Untreated active infection

Trial design

Design model

Single group

Treatments tested in this trial

  • RIRS using the TaloStone T1000 RIRS platform

    Procedure/Surgery

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: RIRS armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Success rate

Successful RIRS by the robotic system, i.e. without conversion to conventional manual RIRS

Time frame
Intra-operative

Secondary outcomes

1

Stone free rate

* by non-contrast computer tomography (NCCT) performed within 1 month of surgery * without residual stone fragments, or residual stone fragments \<2mm

Time frame
Within post-operative 1 month
2

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

Time frame
Intra-operative
3

Total laser energy used

Laser energy in terms of kJ

Time frame
Intra-operative
4

Total radiation dose during operation

Radiation dose based on fluoroscopy readings

Time frame
Intra-operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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