Urinary Tract StonePhase 4NCT04963062
Moses vs. Thulium Laser Study
A Phase 4 study testing Holmium laser with Moses lasers and Holmium laser with thulium lasers in people with Urinary Tract Stone, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Urinary Tract Stone
- What is being tested?
- Holmium laser with Moses lasers and Holmium laser with thulium lasers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 2 May 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Urinary Tract Stone
- Being tested
- Holmium laser with Moses lasers, Holmium laser with thulium lasers
- Keywords
- Lithotripsy, Holmium laser
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium laser with Moses lasersDevice
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 lasersDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with Holmium laser with the Moses laser | Experimental | Not described Receives: Device: Holmium laser with Moses lasers |
| Participants treated with Holmium laser with the thulium laser | Experimental | Not described Receives: Device: Holmium laser with thulium lasers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 hours
Secondary outcomes (8)
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.
Measured: Baseline(pre-operative) and approximately 8 weeks
Lasing Time (Minutes)
Time the laser was in use, not including pedal pauses
Measured: up to 6 hours
Total Energy Used (Kilojoules)
The total energy used to fragment the stones into small pieces (≤2 mm)
Measured: up to 6 hours
Ablation Efficiency (J/mm^3)
It is a ratio of ablated stone volume to the laser pulse energy (J/mm3)
Measured: up to 6 hours
Number of Participants With Post-operative Complications
Measured: 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.
Measured: Baseline(pre-operative) and approximately 8 weeks (1 month post-operative)
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.
Measured: Up to 6 hours
Ablation Speed
The speed to fragment or dust stones
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start16 Jul 2021
- Primary completion30 May 2022
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized (ratio 1:1) at the time of enrollment to be treated with either the holmium laser with Moses or the thulium laser. Investigators will use Permuted Block Randomization (stratified by stone size 3 - 10 mm or 11-20 mm) (block size 4).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Nakada, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963062
- Sponsor's protocol ID
- 2021-0695
- Other IDs
- A539800, SMPH/UROLOGY/UROLOGY, Protocol ver 11-29-2021
- Status last verified
- Jun 2023
- First submitted
- 6 Jul 2021
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04963062
- Acronym / sponsor ID
- 2021-0695
- Conditions
- Urinary Tract Stone
- Keywords
- Lithotripsy, Holmium laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized (ratio 1:1) at the time of enrollment to be treated with either the holmium laser with Moses or the thulium laser. Investigators will use Permuted Block Randomization (stratified by stone size 3 - 10 mm or 11-20 mm) (block size 4).
| Arm | Type | Receives |
|---|---|---|
| Participants treated with Holmium laser with the Moses laser | Experimental | Device: Holmium laser with Moses lasers |
| Participants treated with Holmium laser with the thulium laser | Experimental | Device: Holmium laser with thulium lasers |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium laser with Moses lasersThe 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. | Device | Participants treated with Holmium laser with the Moses laser |
| Holmium laser with thulium lasersThe 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 | Device | Participants treated with Holmium laser with the thulium laser |
Primary outcome
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.
8 secondary outcomes
Stone Free Rate
Time frame: Baseline(pre-operative) and approximately 8 weeks
Lasing Time (Minutes)
Time frame: up to 6 hours
Total Energy Used (Kilojoules)
Time frame: up to 6 hours
Ablation Efficiency (J/mm^3)
Time frame: up to 6 hours
Number of Participants With Post-operative Complications
Time frame: approximately 8 weeks (1 month post-operative)
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)
Score on the Laser Evaluation Instrument
Time frame: Up to 6 hours
Ablation Speed
Time frame: 0-6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Nakada, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Holmium laser with Moses lasers and Holmium laser with thulium lasers in people with Urinary Tract Stone, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Time (Minutes) (time frame: up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 26 Oct 2026.