NCT05677425

Temperature Profiles During Laser Activation in Ureteroscopic Lithotripsy

Completed NA Results posted Last updated 11 April 2025

What this trial tests

NA trial testing Temperature measurement in Ureteral Stone in 10 participants. Completed in 1 July 2023.

Timeline

23 January 2023

Primary endpoint
30 June 2023

1 July 2023

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	23 January 2023
Primary completion	30 June 2023
Estimated completion	1 July 2023
Sites	1 location across Norway

Drugs / interventions tested

• Temperature measurement

Conditions studied

• Ureteral Stone — all drugs for Ureteral Stone →

Sponsor

Haukeland University Hospital

Who can join

18 and older, any sex, with Ureteral Stone. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Temperature Profiles Primary · During surgery

Temperatures during ureteroscopic laser activation using different laser power settings.

Baseline temperature

Group	Value	95% CI
Temperature Measurement Group	32.5	31.7 – 33.2

Tmax 5 W

Group	Value	95% CI
Temperature Measurement Group	35.3	34.6 – 36.9

Tmax 10 W

Group	Value	95% CI
Temperature Measurement Group	37.9	36.4 – 39.4

Tmax 20 W

Group	Value	95% CI
Temperature Measurement Group	40.0	39.0 – 41.1

Adverse events — posted to ClinicalTrials.gov

Time frame: From study start until 3 months follow-up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Temperature Measurement Group

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	Temperature Measurement Gr…
Clavien-Dindo 1 and 2	Renal and urinary disorders	—

Data from ClinicalTrials.gov NCT05677425 adverse events section.

Sponsor's own description

The primary aim of this study is to investigate the temperature profiles in the renal pelvis during ureteroscopic Thulium Fiber Laser activation using different settings. To this end, comparison of peak temperatures during laser activation for different settings is the main aim. Secondary aim is trying to define the duration of safe laser activation until the threshold for heat induced cell injury (43oC) is reach.

Patients ≥ 18 years with a ureteral stone (with or without a concomitant renal stone) and an indwelling nephrostomy tube scheduled for ureteroscopic lithotripsy at the day surgery unit at Haukeland University Hospital, are eligible to enrolment in the study.

Temperature measurements during ureteroscopic laser stone disintegration will be performed. Follow-up is standardised with clinical consultation and low dose CT 3 months post endoscopically.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Temperature Measurements During Flexible Ureteroscopic Laser Lithotripsy: A Prospective Clinical Trial.
   Æsøy MS, Juliebø-Jones P, Beisland C, Ulvik Ø. · · 2024 · cited 17× · PMID 38185920 · DOI 10.1089/end.2023.0660