Moses vs. Thulium Laser Study

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Stone

Treatments: Device: Holmium laser with thulium lasers; Device: Holmium laser with Moses lasers

Study type: Interventional

Funder types: Other

Identifiers

NCT04963062

A539800 (Other Identifier)

2021-0695

SMPH/UROLOGY/UROLOGY (Other Identifier)

Protocol ver 11-29-2021 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

114 participants in 2 patient groups

Participants treated with Holmium laser with the Moses laser

Experimental group

Treatment:

Device: Holmium laser with Moses lasers

Participants treated with Holmium laser with the thulium laser

Experimental group

Treatment:

Device: Holmium laser with thulium lasers