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High Versus Low Power Settings During Ureteroscopic Laser Lithotripsy

NCT05697250 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-05

No results posted yet for this study

Summary

The primary aim of the study is to compare the operative times following ureteroscopic lithotripsy for renal stones with Thulium Fiber Laser using low and high power settings.

Secondary aims are to compare the results of low and high power settings in terms of stone free rates, laser time, laser activation patterns, intraoperative and postoperative complications.

Patients ≥ 18 years with renal stones (8-25 mm) scheduled for ureteroscopic lithotripsy at the Day Surgery Clinic at Haukeland University Hospital in Bergen, Norway, are eligible for inclusion in the study. After written consent and inclusion, patients are randomised to laser lithotripsy using either low power settings (Group 1: 4-6 Watt, short pulse mode) or high power settings (Group 2: 16-18 Watt, short pulse mode). The ureteroscopic procedures are performed in general anaesthesia using a standardised technique. All patients are followed up with a low dose CT scan 3 months post endoscopically to assess stone free status as well as a consultation at the outpatient clinic.

Results and data for the two randomisation groups are compared according to the aims of the study.

Conditions

  • Renal Stone

Interventions

OTHER

Laser power settings (Thulium Fiber Laser)

Ureteroscopic lithotripsy using low power laser settings (0.4 - 0.6 J at 10 Hz corresponding to 2.4 - 6.0 Watts) or high power laser settings (0.4 J at 40 Hz, 0.6 J at 30 Hz or 0.8 J at 20 Hz corresponding to 16 - 18 Watts).

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Øyvind Ulvik, Assoc Prof · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05697250 on ClinicalTrials.gov