Phase 4
N=114
Moses vs. Thulium Laser Study
Urinary Tract Stone
Bottom Line
View on ClinicalTrials.gov: NCT04963062 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Procedural Time (Minutes) — 20; 17 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Holmium laser with Moses lasers (Device); Holmium laser with thulium lasers (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedural Time (Minutes) |
20; 17 | — |
| SECONDARY Stone Free Rate |
40; 40 | — |
| SECONDARY Lasing Time (Minutes) |
2.7; 3.6 | — |
| SECONDARY Total Energy Used (Kilojoules) |
1.2; 2.5 | — |
| SECONDARY Ablation Efficiency (J/mm^3) |
1.5; 1.8 | — |
| SECONDARY Number of Participants With Post-operative Complications |
5; 6 | — |
| SECONDARY Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively |
51.5; 49; 75.3; 84.3 | — |
| SECONDARY Score on the Laser Evaluation Instrument |
4.3; 4.5 | — |
| SECONDARY Ablation Speed |
482; 413 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04963062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.