Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

Not Applicable

Withdrawn

• Conditions: Renal Stone; Ureter Stone; Kidney Stone
• Interventions: Device: Short Pulse Duration; Device: Long Pulse Duration

• Registration Number: NCT03608098
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-31
• Status Verified: 2018-12
• Study Start: 2019-05
• Last Update Submitted: 2019-05-30
• Last Update Posted: 2019-06-03
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Kidney/ureter single stone between up to 2 cm
• Age over 18 years
• Two kidneys

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Exclusion Criteria

• Solitary Kidney
• Age under 18
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short Pulse Duration Group	Short Pulse Duration	A short pulse duration (300 μs or 350 μs) will be used in this group.
Long Pulse Duration Group	Long Pulse Duration	A long laser pulse duration (700 μs or 1500 μs) will be used in this group.

Primary Outcome Measures

Name	Time	Method
Stone free rate	1 month after surgery	Proportion of participants free of stones after procedure reported by group

Secondary Outcome Measures

Name	Time	Method
Operative duration time	1 month after surgery	Operative duration time measured by minutes
Need for Secondary Procedures	1 month after surgery	The number of participants needing additional secondary procedures will be reported per group

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States