Skip to main content
OpenTrials
Completed

NCT Number: NCT04963062

Moses vs. Thulium Laser Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Tract Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Holmium laser with Moses lasers

Device

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

Device

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

Primary outcomes

  1. Procedural Time (Minutes)

    Time frame: 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.

Secondary outcomes

  1. Stone Free Rate

    Time frame: Baseline(pre-operative) and approximately 8 weeks

    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.

  2. Lasing Time (Minutes)

    Time frame: up to 6 hours

    Time the laser was in use, not including pedal pauses

  3. Total Energy Used (Kilojoules)

    Time frame: up to 6 hours

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

  4. Ablation Efficiency (J/mm^3)

    Time frame: up to 6 hours

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

  5. Number of Participants With Post-operative Complications

    Time frame: approximately 8 weeks (1 month post-operative)

  6. Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively

    Time frame: 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.

  7. Score on the Laser Evaluation Instrument

    Time frame: Up to 6 hours

    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.

  8. Ablation Speed

    Time frame: 0-6 hours

    The speed to fragment or dust stones

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 15, 2021
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.