Moses vs. Thulium Laser Study

Phase 4

Completed

Interventions: Device: Holmium laser with Moses lasers
Device: Holmium laser with thulium lasers

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Participants treated with Holmium laser with the Moses laser	Holmium laser with Moses lasers	-
Participants treated with Holmium laser with the thulium laser	Holmium laser with thulium lasers	-

Primary Outcome Measures

Name	Time	Method
Procedural Time (Minutes)	up to 6 hours	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.

Secondary Outcome Measures

Name	Time	Method
Ablation Speed	0-6 hours	The speed to fragment or dust stones
Stone Free Rate	Baseline(pre-operative) and approximately 8 weeks	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.
Total Energy Used (Kilojoules)	up to 6 hours	The total energy used to fragment the stones into small pieces (≤2 mm)
Number of Participants With Post-operative Complications	approximately 8 weeks (1 month post-operative)
Lasing Time (Minutes)	up to 6 hours	Time the laser was in use, not including pedal pauses
Ablation Efficiency (J/mm^3)	up to 6 hours	It is a ratio of ablated stone volume to the laser pulse energy (J/mm3)
Score on the Laser Evaluation Instrument	Up to 6 hours	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.
Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively	Baseline(pre-operative) and approximately 8 weeks (1 month post-operative)	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.