Trial Outcomes & Findings for Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones (NCT NCT06070714)
NCT ID: NCT06070714
Last Updated: 2026-02-27
Results Overview
The primary objective of this study is to compare the stone free rate as determined by ultra-low dose limited renal CT at 2 months post operatively between the holmium laser with pulse modulation and the thulium fiber laser.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
178 participants
Primary outcome timeframe
Post-operative (up to 10 weeks)
Results posted on
2026-02-27
Participant Flow
Participant milestones
| Measure |
Holmium Laser With Pulse Modulation
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
89
|
|
Overall Study
COMPLETED
|
68
|
65
|
|
Overall Study
NOT COMPLETED
|
21
|
24
|
Reasons for withdrawal
| Measure |
Holmium Laser With Pulse Modulation
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Overall Study
Patients who did not complete post-operative CT
|
21
|
24
|
Baseline Characteristics
Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones
Baseline characteristics by cohort
| Measure |
Holmium Laser With Pulse Modulation
n=89 Participants
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
n=89 Participants
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=24 Participants
|
83 Participants
n=20 Participants
|
164 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 16.1 • n=24 Participants
|
58 years
STANDARD_DEVIATION 14.5 • n=20 Participants
|
57.4 years
STANDARD_DEVIATION 15.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=24 Participants
|
44 Participants
n=20 Participants
|
91 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=24 Participants
|
45 Participants
n=20 Participants
|
87 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=24 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=24 Participants
|
85 Participants
n=20 Participants
|
170 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=24 Participants
|
89 participants
n=20 Participants
|
178 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Post-operative (up to 10 weeks)The primary objective of this study is to compare the stone free rate as determined by ultra-low dose limited renal CT at 2 months post operatively between the holmium laser with pulse modulation and the thulium fiber laser.
Outcome measures
| Measure |
Holmium Laser With Pulse Modulation
n=68 Participants
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
n=65 Participants
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Stone Free Rate
|
36 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: day of procedure (up to 3 hours)Time from the start of lasing to the end of lasing.
Outcome measures
| Measure |
Holmium Laser With Pulse Modulation
n=89 Participants
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
n=89 Participants
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Stone Treatment Time in Minutes
|
15.7 minutes
Standard Deviation 16.8
|
12.7 minutes
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: day of procedure (up to 3 hours)Time from the insert to removal of the instrument.
Outcome measures
| Measure |
Holmium Laser With Pulse Modulation
n=89 Participants
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
n=89 Participants
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Procedural Time
|
43.6 minutes
Standard Deviation 21.9
|
40 minutes
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: day of procedure (up to 3 hours)The total energy used for the stone surgery is documented by the laser machine. With reported case averages ranging from 0.1 to 42.1 kJ depending on stone size and technique (e.g., dusting vs. fragmentation).This parameter is a measure of the efficiency of stone treatment.
Outcome measures
| Measure |
Holmium Laser With Pulse Modulation
n=89 Participants
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
n=89 Participants
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Total Energy Used in Kilojoules
|
5.6 kilojoules
Standard Deviation 7
|
5.1 kilojoules
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: day of procedure (up to 10 weeks)All complications are documented during the procedure and the total follow-up time (up to 10 weeks). This outcome measure include the procedural complications and post-operative complications.
Outcome measures
| Measure |
Holmium Laser With Pulse Modulation
n=89 Participants
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
n=89 Participants
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Number of Participants With Complications
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: before the procedure (up to 3 hours before procedures)WISQOL short form is a 6 item questionnaire which can be scored from 1(worst outcome) to 5 (best outcome). The raw score range is 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes.
Outcome measures
| Measure |
Holmium Laser With Pulse Modulation
n=89 Participants
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
n=89 Participants
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Participant Quality of Life as Measured by the WISQOL Short Form Score Pre-procedure Assessment
|
73.1 score on a scale
Standard Deviation 28.9
|
70 score on a scale
Standard Deviation 28
|
SECONDARY outcome
Timeframe: Post-operative (up to 10 weeks)WISQOL short form is a 6 item questionnaire which can be scored from 1 (worst outcome) to 5 (best outcome). The raw score range is 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes.
Outcome measures
| Measure |
Holmium Laser With Pulse Modulation
n=68 Participants
Holmium laser with pulse modulation: The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
|
Thulium Fiber Laser
n=65 Participants
Thulium fiber laser: The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
|
|---|---|---|
|
Participant Quality of Life as Measured by the WISQOL Short Form Score Post-procedure Assessment
|
93 score on a scale
Standard Deviation 15.5
|
88.2 score on a scale
Standard Deviation 20.2
|
Adverse Events
Holmium Laser With Pulse Modulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thulium Fiber Laser
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place