Trial Outcomes & Findings for Moses vs. Thulium Laser Study (NCT NCT04963062)

NCT ID: NCT04963062

Last Updated: 2023-06-22

Results Overview

Time from the minute the ureteroscope is inserted into the participant to the time the ureteroscope has been removed will be reported as procedural time.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 114 participants
• Primary outcome timeframe: up to 6 hours
• Results posted on: 2023-06-22

Participant Flow

Participant milestones

Measure	Participants Treated With Holmium Laser With the Moses Laser Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses 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	56	58
Overall Study COMPLETED	52	56
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Participants Treated With Holmium Laser With the Moses Laser Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses 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 withdrew by the study team	4	2

Baseline Characteristics

Moses vs. Thulium Laser Study

Baseline characteristics by cohort

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses 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=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	36 Participants n=7 Participants	69 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Age, Continuous	61.1 years STANDARD_DEVIATION 12.8 • n=5 Participants	59.6 years STANDARD_DEVIATION 11.3 • n=7 Participants	60.3 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	56 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 hours

Time from the minute the ureteroscope is inserted into the participant to the time the ureteroscope has been removed will be reported as procedural time.

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score Quality of life assessment after treatment for patients treated with thulium laser.
Procedural Time (Minutes)	20 minutes Interval 11.0 to 28.0	17 minutes Interval 13.0 to 24.0	—	—

SECONDARY outcome

Timeframe: Baseline(pre-operative) and approximately 8 weeks

Population: patients who did not have post operative image were not able to access stone free rate

Stone free rate (SFR) (%) are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the urinary tract which were defined as ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=47 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=53 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score Quality of life assessment after treatment for patients treated with thulium laser.
Stone Free Rate	40 Participants	40 Participants	—	—

SECONDARY outcome

Timeframe: up to 6 hours

Time the laser was in use, not including pedal pauses

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score Quality of life assessment after treatment for patients treated with thulium laser.
Lasing Time (Minutes)	2.7 minutes Interval 1.2 to 6.7	3.6 minutes Interval 1.7 to 7.3	—	—

SECONDARY outcome

Timeframe: up to 6 hours

The total energy used to fragment the stones into small pieces (≤2 mm)

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score Quality of life assessment after treatment for patients treated with thulium laser.
Total Energy Used (Kilojoules)	1.2 KJ Interval 0.5 to 4.7	2.5 KJ Interval 1.4 to 5.6	—	—

SECONDARY outcome

Timeframe: up to 6 hours

It is a ratio of ablated stone volume to the laser pulse energy (J/mm3)

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score Quality of life assessment after treatment for patients treated with thulium laser.
Ablation Efficiency (J/mm^3)	1.5 J/mm^3 Interval 0.7 to 2.2	1.8 J/mm^3 Interval 1.1 to 3.2	—	—

SECONDARY outcome

Timeframe: approximately 8 weeks (1 month post-operative)

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score Quality of life assessment after treatment for patients treated with thulium laser.
Number of Participants With Post-operative Complications	5 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Baseline(pre-operative) and approximately 8 weeks (1 month post-operative)

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 5-30. In the study, standardized total score is used. the range of the standardized total score is 0-100.

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score n=52 Participants Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score n=56 Participants Quality of life assessment after treatment for patients treated with thulium laser.
Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively	51.5 score on a scale Standard Deviation 32.6	49 score on a scale Standard Deviation 33.1	75.3 score on a scale Standard Deviation 33.1	84.3 score on a scale Standard Deviation 19.1

SECONDARY outcome

Timeframe: Up to 6 hours

Population: Evaluation of the efficiency of the two lasers

Physician evaluation of the laser will be done by Laser Evaluation Instrument. It consists of 6 items which can be scored from 0(worst outcome) to 5 (best outcome). Cumulative score may range from 0-30.

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score Quality of life assessment after treatment for patients treated with thulium laser.
Score on the Laser Evaluation Instrument	4.3 score on a scale Standard Deviation 0.5	4.5 score on a scale Standard Deviation 0.5	—	—

SECONDARY outcome

Timeframe: 0-6 hours

The speed to fragment or dust stones

Outcome measures

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 Participants Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 Participants Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns	Participants Treated With Holmium Laser With the Moses Laser Post Operative Score Quality of life assessment after treatment for patients treated with moses laser.	Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score Quality of life assessment after treatment for patients treated with thulium laser.
Ablation Speed	482 mm^3 per minute Interval 205.0 to 868.0	413 mm^3 per minute Interval 273.0 to 692.0	—	—

Adverse Events

Participants Treated With Holmium Laser With the Moses Laser

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Participants Treated With Holmium Laser With the Thulium Laser

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Participants Treated With Holmium Laser With the Moses Laser n=52 participants at risk Holmium laser with Moses lasers: The holmium laser with Moses is FDA approved. It 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. The goal is to increase stone ablative volume and decrease retropulsion of the stone.	Participants Treated With Holmium Laser With the Thulium Laser n=56 participants at risk Holmium laser with thulium lasers: The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns
Renal and urinary disorders Obstructing fragments required surgical treatment	1.9% 1/52 • Number of events 1 • 8 weeks	3.6% 2/56 • Number of events 2 • 8 weeks
Renal and urinary disorders Obstructing fragments passed	1.9% 1/52 • Number of events 1 • 8 weeks	0.00% 0/56 • 8 weeks
Renal and urinary disorders ER visit and discharge	1.9% 1/52 • Number of events 1 • 8 weeks	5.4% 3/56 • Number of events 3 • 8 weeks
Renal and urinary disorders UTI treated with outpatient antibiotics	3.8% 2/52 • Number of events 2 • 8 weeks	1.8% 1/56 • Number of events 1 • 8 weeks

Additional Information

Shuang Li

University of Wisconsin School of Medicine and Public Health

Phone: 608.263.8336

Email: lis@urology.wisc.edu

Results disclosure agreements

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