Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346483
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-22
Brief Title:
Ureteroscopy With High-powered HolmiumYag Laser Lithotripsy With and Moses On or Moses Off
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Comparison of Ureteroscopy With High-powered HolmiumYag Laser Lithotripsy With and Without Moses 20 Pulse Modulation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare Moses 20 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 20 laser technology is FDA approved and currently used in practice since 2021 No study to this date has compared Moses 20 without pulse modulation laser technology to Moses 20 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
Currently Moses 20 laser technology is FDA approved and currently used in practice since 2021 No study to this date has compared Moses 20 without pulse modulation laser technology to Moses 20 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
Detailed 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 20 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 heshe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None