Trial Outcomes & Findings for Temperature Profiles During Laser Activation in Ureteroscopic Lithotripsy (NCT NCT05677425)

NCT ID: NCT05677425

Last Updated: 2025-04-11

Results Overview

Temperatures during ureteroscopic laser activation using different laser power settings.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

During surgery

Results posted on

2025-04-11

Participant Flow

Participant milestones

Participant milestones
Measure
Temperature Measurement Group
Temperature measurement in the renal pelvis during ureteroscopic laser stone disintegration. Temperature measurement will be performed using different laser power settings. Temperature measurement: Temperature measurement in the renal pelvis during ureteroscopic laser activation.
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Temperature Measurement Group
n=10 Participants
Temperature measurement in the renal pelvis during ureteroscopic laser stone disintegration. Temperature measurement will be performed using different laser power settings. Temperature measurement: Temperature measurement in the renal pelvis during ureteroscopic laser activation.
Age, Continuous
57 years
n=10 Participants
Sex: Female, Male
Female
8 Participants
n=10 Participants
Sex: Female, Male
Male
2 Participants
n=10 Participants
Stone size, mm
9 mm
n=10 Participants

PRIMARY outcome

Timeframe: During surgery

Temperatures during ureteroscopic laser activation using different laser power settings.

Outcome measures

Outcome measures
Measure
Temperature Measurement Group
n=10 Participants
Temperature measurement in the renal pelvis during ureteroscopic laser stone disintegration. Temperature measurement will be performed using different laser power settings. Temperature measurement: Temperature measurement in the renal pelvis during ureteroscopic laser activation.
Temperature Profiles
Baseline temperature
32.5 Degrees Celcius
Interval 31.7 to 33.2
Temperature Profiles
Tmax 5 W
35.3 Degrees Celcius
Interval 34.6 to 36.9
Temperature Profiles
Tmax 10 W
37.9 Degrees Celcius
Interval 36.4 to 39.4
Temperature Profiles
Tmax 20 W
40.0 Degrees Celcius
Interval 39.0 to 41.1

Adverse Events

Temperature Measurement Group

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Temperature Measurement Group
n=10 participants at risk
Temperature measurement in the renal pelvis during ureteroscopic laser stone disintegration. Temperature measurement will be performed using different laser power settings. Temperature measurement: Temperature measurement in the renal pelvis during ureteroscopic laser activation.
Renal and urinary disorders
Clavien-Dindo 1 and 2
30.0%
3/10 • Number of events 3 • From study start until 3 months follow-up.
Adverse events are reported according to Clavien-Dindo.

Additional Information

Øyvind Ulvik

Haukeland University Hospital

Phone: +47 97 50 00

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place