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
| 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.
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|---|---|
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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
| 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.
|
|---|---|
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Age, Continuous
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57 years
n=10 Participants
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Sex: Female, Male
Female
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8 Participants
n=10 Participants
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Sex: Female, Male
Male
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2 Participants
n=10 Participants
|
|
Stone size, mm
|
9 mm
n=10 Participants
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PRIMARY outcome
Timeframe: During surgeryTemperatures during ureteroscopic laser activation using different laser power settings.
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.
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|---|---|
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Temperature Profiles
Baseline temperature
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32.5 Degrees Celcius
Interval 31.7 to 33.2
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Temperature Profiles
Tmax 5 W
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35.3 Degrees Celcius
Interval 34.6 to 36.9
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Temperature Profiles
Tmax 10 W
|
37.9 Degrees Celcius
Interval 36.4 to 39.4
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Temperature Profiles
Tmax 20 W
|
40.0 Degrees Celcius
Interval 39.0 to 41.1
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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
| 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.
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|---|---|
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Renal and urinary disorders
Clavien-Dindo 1 and 2
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30.0%
3/10 • Number of events 3 • From study start until 3 months follow-up.
Adverse events are reported according to Clavien-Dindo.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place