Moses vs. Thulium Laser Study

Urinary Tract Stone Clinical Trial

Official title:

Randomized Clinical Trial Evaluating the Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Laser on Renal and Ureteral Stones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963062
• Other study ID #: 2021-0695
• Secondary ID: A539800SMPH/UROL
• Status: Completed
• Phase: Phase 4
• Start date: July 16, 2021
• Est. completion date: May 2, 2023

Study information

• Verified date: June 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United States are affected by renal stone disease. This has led to an increased demand on Urologists for efficient and safe surgical treatment of stone disease. Over the past two decades, ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and renal stones globally. The holmium laser is considered the gold standard for laser lithotripsy. Holmium laser lithotripsy with Moses and the thulium laser are new technologies meant to improve the efficiency of laser lithotripsy. Both are FDA approved treatment modalities for stone disease. Two in vitro studies have compared Moses versus thulium and shown that thulium has higher ablative volumes then the holmium laser with Moses, but no clinical trials have compared the two treatment modalities. In this study, investigators are going to conduct a prospective, randomized clinical trial to determine whether there is a difference in procedural time, intraoperative parameters or stone free rate between the Holmium laser with Moses and the thulium laser. This is significant as this may lead to shorter overall operative times, which may result in decreased operative costs and complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 2, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Participants with renal or ureteral urinary stones who require endoscopic treatment in the outpatient operating room
• Participant's stone size in a single renal unit of 3-10 mm and 11-20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT. Participants with multiple stones will be included as long as their largest stone size falls within the above parameters.

Exclusion Criteria:

• Participants under 18 years of age and over 89 years old.
• Pregnant participants
• Participants with transplant kidneys
• Participants with irreversible coagulopathy
• Participants with known ureteral stricture disease
• Participants who do not have a pre-operative CT.
• Non-English speaking, vulnerable participants such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.

Related Conditions & MeSH terms

• Urinary Calculi
• Urinary Tract Stone

Intervention

Device:
• 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.
• 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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Time (Minutes)	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.	up to 6 hours
Secondary	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.	Baseline(pre-operative) and approximately 8 weeks
Secondary	Lasing Time (Minutes)	Time the laser was in use, not including pedal pauses	up to 6 hours
Secondary	Total Energy Used (Kilojoules)	The total energy used to fragment the stones into small pieces (=2 mm)	up to 6 hours
Secondary	Ablation Efficiency (J/mm^3)	It is a ratio of ablated stone volume to the laser pulse energy (J/mm3)	up to 6 hours
Secondary	Number of Participants With Post-operative Complications		approximately 8 weeks (1 month post-operative)
Secondary	Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively	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.	Baseline(pre-operative) and approximately 8 weeks (1 month post-operative)
Secondary	Score on the Laser Evaluation Instrument	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.	Up to 6 hours
Secondary	Ablation Speed	The speed to fragment or dust stones	0-6 hours