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Moses vs. Thulium Laser Study
Phase 4 trial testing Holmium laser with Moses lasers in Urinary Tract Stone in 114 participants. Completed in 2 May 2023.
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 114 |
| Start date | 16 July 2021 |
| Primary completion | 30 May 2022 |
| Estimated completion | 2 May 2023 |
| Sites | 1 location across United States |
University of Wisconsin, Madison
Adults 18 to 89, any sex, with Urinary Tract Stone. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | 20 | 11 – 28 |
| Participants Treated With Holmium Laser With the Thulium Laser | 17 | 13 – 24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | 40 | |
| Participants Treated With Holmium Laser With the Thulium Laser | 40 |
Time the laser was in use, not including pedal pauses
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | 2.7 | 1.2 – 6.7 |
| Participants Treated With Holmium Laser With the Thulium Laser | 3.6 | 1.7 – 7.3 |
The total energy used to fragment the stones into small pieces (≤2 mm)
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | 1.2 | 0.5 – 4.7 |
| Participants Treated With Holmium Laser With the Thulium Laser | 2.5 | 1.4 – 5.6 |
It is a ratio of ablated stone volume to the laser pulse energy (J/mm3)
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | 1.5 | 0.7 – 2.2 |
| Participants Treated With Holmium Laser With the Thulium Laser | 1.8 | 1.1 – 3.2 |
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | 5 | |
| Participants Treated With Holmium Laser With the Thulium Laser | 6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser Pre Operative Score | 51.5 | ± 32.6 |
| Participants Treated With Holmium Laser With the Thulium Laser Pre Operative Score | 49 | ± 33.1 |
| Participants Treated With Holmium Laser With the Moses Laser Post Operative Score | 75.3 | ± 33.1 |
| Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score | 84.3 | ± 19.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | 4.3 | ± 0.5 |
| Participants Treated With Holmium Laser With the Thulium Laser | 4.5 | ± 0.5 |
The speed to fragment or dust stones
| Group | Value | 95% CI |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | 482 | 205 – 868 |
| Participants Treated With Holmium Laser With the Thulium Laser | 413 | 273 – 692 |
Time frame: 8 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Participants Treated With … | Participants Treated With … |
|---|---|---|---|
| ER visit and discharge | Renal and urinary disorders | — | — |
| Obstructing fragments required surgical treatment | Renal and urinary disorders | — | — |
| UTI treated with outpatient antibiotics | Renal and urinary disorders | — | — |
| Obstructing fragments passed | Renal and urinary disorders | — | — |
Data from ClinicalTrials.gov NCT04963062 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04963062.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing