Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Renal Stone; Kidney Stone; Ureter Stone

Treatments: Device: Short Pulse Duration; Device: Long Pulse Duration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03608098

IRB00049526

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Short Pulse Duration Group

Active Comparator group

Description:

A short pulse duration (300 μs or 350 μs) will be used in this group.

Treatment:

Device: Short Pulse Duration

Long Pulse Duration Group

Active Comparator group

Description:

A long laser pulse duration (700 μs or 1500 μs) will be used in this group.

Treatment:

Device: Long Pulse Duration