Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

Kidney Stone Clinical Trial

Official title:

Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03608098
• Other study ID #: IRB00049526
• Status: Withdrawn
• Phase: N/A
• Start date: May 2019
• Est. completion date: December 2023

Study information

• Verified date: December 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to compare how well two treatments work for removing kidney stones. The two study groups include ureteroscopy with long/short pulse lithotripsy to remove kidney stones. Both of these options are considered standard of care and are used currently in surgery.

Description:

This study will compare two types of laser lithotripsy to see the pulse duration to determine which settings are more effective. This is a randomized control trial with subjects randomized to either long pulse or a short pulse group. Those subjects with a single kidney/ureter stone measuring up to 20 mm will be eligible for the study. The procedures will be performed using the standard of care instruments and techniques but the pulse type setting in surgery will be constant. Some Holmium laser devices provide the option to modulate the pulse duration. A longer laser pulse duration (700 μs or 1500 μs) as compared to a traditional pulse duration (300 μs or 350 μs) has been demonstrated in vitro studies to provide effective stone disintegration while reducing laser fiber tip degradation and stone retropulsion. Both the long and the short setting can dust the stone and currently we alternate in each procedure from one setting to the other and it is unclear which setting is more effective. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. All subjects will be seen one week to one month after surgery for stent removal and follow up.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Kidney/ureter single stone between up to 2 cm

• Age over 18 years

• Two kidneys

Exclusion Criteria:

• Solitary Kidney

• Age under 18

• Pregnancy

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Renal Stone
• Ureter Stone
• Ureteral Calculi
• Ureterolithiasis

Intervention

Device:
• Short Pulse Duration
The holmium laser device will be used on a short laser pulse duration setting (300 µs or 350 µs)
• Long Pulse Duration
The holmuim laser device will be used on a long laser pulse duration setting (700 µs or 1500 µs)

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Cogenix Medical Corporation

Country where clinical trial is conducted

United States, 

References & Publications (5)

Chew BH, Brotherhood HL, Sur RL, Wang AQ, Knudsen BE, Yong C, Marien T, Miller NL, Krambeck AE, Charchenko C, Humphreys MR. Natural History, Complications and Re-Intervention Rates of Asymptomatic Residual Stone Fragments after Ureteroscopy: a Report from the EDGE Research Consortium. J Urol. 2016 Apr;195(4 Pt 1):982-6. doi: 10.1016/j.juro.2015.11.009. Epub 2015 Nov 14. — View Citation

Li R, Ruckle D, Keheila M, Maldonado J, Lightfoot M, Alsyouf M, Yeo A, Abourbih SR, Olgin G, Arenas JL, Baldwin DD. High-Frequency Dusting Versus Conventional Holmium Laser Lithotripsy for Intrarenal and Ureteral Calculi. J Endourol. 2017 Mar;31(3):272-277. doi: 10.1089/end.2016.0547. Epub 2017 Jan 16. — View Citation

Matlaga et al. Ureteroscopic Laser Lithotripsy: A Review of Dusting Versus Fragmentation With Extraction. Journal of Endourology. October 2017. Epub ahead of publication.

Nelson CP, Pace KT, Pais VM, Pearle MS, Preminger GM. American Urological Association (AUA) guideline surgical management of stones: American Urological Association Surgical Management 2016; April:1-50.

Wollin DA, Ackerman A, Yang C, Chen T, Simmons WN, Preminger GM, Lipkin ME. Variable Pulse Duration From a New Holmium:YAG Laser: The Effect on Stone Comminution, Fiber Tip Degradation, and Retropulsion in a Dusting Model. Urology. 2017 May;103:47-51. doi: 10.1016/j.urology.2017.01.007. Epub 2017 Jan 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate	Proportion of participants free of stones after procedure reported by group	1 month after surgery
Secondary	Operative duration time	Operative duration time measured by minutes	1 month after surgery
Secondary	Need for Secondary Procedures	The number of participants needing additional secondary procedures will be reported per group	1 month after surgery