Moses vs. Thulium Laser Study
Condition: Urinary Tract Stone
MeSH terms: Urinary Calculi
Intervention: Holmium laser with Moses lasers; Holmium laser with thulium lasers
Intervention description: 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.; 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
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).
Masking: Single (Participant)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Lithotripsy; Holmium laser

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.