Clinical trial NCT04963062: Moses vs. Thulium Laser 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Stone
Keywords: Lithotripsy
Holmium laser
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Procedural Time (Minutes)
timeFrame: up to 6 hours
Secondary outcomes:
measure: Stone Free Rate
timeFrame: Baseline(pre-operative) and approximately 8 weeks
measure: Lasing Time (Minutes)
timeFrame: up to 6 hours
measure: Total Energy Used (Kilojoules)
timeFrame: up to 6 hours
measure: Ablation Efficiency (J/mm^3)
timeFrame: up to 6 hours
measure: Number of Participants With Post-operative Complications
timeFrame: approximately 8 weeks (1 month post-operative)
measure: Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively
timeFrame: Baseline(pre-operative) and approximately 8 weeks (1 month post-operative)
measure: Score on the Laser Evaluation Instrument
timeFrame: Up to 6 hours
measure: Ablation Speed
timeFrame: 0-6 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stephen Nakada, MD
role: PRINCIPAL_INVESTIGATOR
References: