Moses vs. Thulium Laser Study

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Stone
• Intervention / Treatment: Device: Holmium laser with Moses lasers; Device: Holmium laser with thulium lasers

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants treated with Holmium laser with the Moses laser	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.
Experimental: Participants treated with Holmium laser with the thulium laser	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Lasing Time (Minutes)	Time the laser was in use, not including pedal pauses	up to 6 hours
Total Energy Used (Kilojoules)	The total energy used to fragment the stones into small pieces (≤2 mm)	up to 6 hours
Ablation Efficiency (J/mm^3)	It is a ratio of ablated stone volume to the laser pulse energy (J/mm3)	up to 6 hours
Number of Participants With Post-operative Complications		approximately 8 weeks (1 month post-operative)
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)
Ablation Speed	The speed to fragment or dust stones	0-6 hours

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Stephen Nakada, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Lithotripsy; Holmium laser
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi
• Other Study ID Numbers: 2021-0695; A539800 (Other Identifier: UW Madison); SMPH/UROLOGY/UROLOGY (Other Identifier: UW Madison); Protocol ver 11-29-2021 (Other Identifier: HS-IRB UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No