Health TrialsbyHealthPanel

Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones

ConditionRenal Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

This is a prospective randomized clinical trial which aims to compare the clinical outcomes of robotic flexible ureteroscopy and standard flexible ureteroscopy for the treatment of renal stones.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old with informed consent

Being willing and able to provide written informed consent

Disqualifiers

Patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture)

American Society of Anesthesiologists (ASA) physical status classification system >3

Untreated urinary tract infection

Renal stones > 3cm in diameter

Trial design

Design model

Parallel

Treatments tested in this trial

  • Flexible Ureteroscopy

    Procedure/Surgery

    Ureteroscopic lithotripsy

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Robotic flexible ureteroscopy with ILY® Robot platformExperimental treatment 1 intervention
Group B: Standard flexible ureteroscopyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stone-free rate at 1 month

Stone-free rate at 1 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments \<2mm

Time frame
Month 1

Secondary outcomes

1

Stone-free rate at 3 month

If not stone free at 1 month, stone-free rate at 3 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments \<2mm

Time frame
Month 3
2

Operative time

the time from insertion of an endoscope into the urethra to the completion of stent placement

Time frame
During operation
3

Lasing Time

The total lasing time in minutes during operation

Time frame
During operation
4

Total laser energy used

Total laser energy used during operation

Time frame
During operation

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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