Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off

Kidney Stone Clinical Trial

Official title:

Comparison of Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Without Moses 2.0 Pulse Modulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346483
• Other study ID #: STU00218929
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: June 9, 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Alyssa McDonald, MPH
• Phone: 312-695-8146
• Email: alyssa.mcdonald[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it will affect time in the operating room, time using the laser, laser energy, and stone free rates.

Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology.

The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

Description:

On the day of surgery, the treatment assigned to the patient will be determined by chance, like flipping a coin. Neither the patient nor the study doctor will choose the treatment type. Each patient will have an equal chance of being given either surgical treatment. One group will have stones treated with high powered laser dusting with Moses 2.0 pulse modulation and the dust produced will pass spontaneously through the urine. The other group will have stones treated with standard of care high power laser fragmentation and the dust produced will pass spontaneously through the urine. The surgical procedure will not differ from the treatment a patient would receive if he/she were not in this study.

8 to 12 weeks after surgery, participants will undergo a standard of care renal bladder ultrasound (RBUS) and Kidney Ureter Bladder Abdominal X-ray (KUB) to evaluate for stones and hydronephrosis, which is swelling of the kidney due to build-up of urine.

If there are abnormal findings on the RBUS or KUM at the 8 to 12 week follow-up, participants will be asked to return to the urology clinic and may have to repeat imaging to ensure participants did not develop a postoperative condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 9, 2025
• Est. primary completion date: June 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Undergoing ureteroscopy and laser lithotripsy

• Stone size =8 but < 20 mm in the proximal ureter or kidney. Multiple stones =4 are allowed. Bilateral surgeries are allowed

• Willing to sign informed consent

Exclusion Criteria:

• Staged surgery

• Nephrocalcinosis

• Participant is less than 18 years of age

• Inability to provide informed consent

• Members of vulnerable patient populations

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Ureteral Calculi
• Ureteral Stone
• Ureterolithiasis

Intervention

Procedure:
• Dusting
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Total amount of time (in minutes) taken to complete the procedure.	Day of procedure
Primary	Stone Free Rate	This is measured by KUB and Renal bladder ultrasound that is post-operative standard of care.; Stone free is defined as no stone fragments seen on KUB or RBUS. If there are hyperechoic fragments seen on RBUS but not KUB and the stone analysis was not uric acid, the patient will be considered stone free. The investigators will also calculate a clinically stone free rate (< 4mm residual fragments allowed).; The Stone Free Rate assessments by the investigators will highlight the rate, or ratio of patients who are stone free and patients who are not stone free after procedure.	6-8 weeks post procedure
Secondary	Lasing time	(no residents, fellows will be allowed under attending supervision)	Day of procedure
Secondary	Total laser energy (kJ)	The energy setting of the laser that is used during procedure.	Day of procedure
Secondary	Detection of postoperative strictures	If postoperative ultrasound shows hydronephrosis at follow up. Repeat Ultrasound will be obtained 1 month later. If hydronephrosis persists, CT urogram will be obtained. If stricture is identified, then appropriate intervention will be recommended.	12 weeks