Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

NCT ID: NCT03608098

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2023-12-31

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.

Conditions

Kidney Stone; Ureter Stone; Renal Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short Pulse Duration Group

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

Group Type: ACTIVE_COMPARATOR

Short Pulse Duration

Intervention Type: DEVICE

The holmium laser device will be used on a short laser pulse duration setting (300 μs or 350 μs)

Long Pulse Duration Group

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

Group Type: ACTIVE_COMPARATOR

Long Pulse Duration

Intervention Type: DEVICE

The holmuim laser device will be used on a long laser pulse duration setting (700 μs or 1500 μs)

Interventions

Short Pulse Duration

The holmium laser device will be used on a short laser pulse duration setting (300 μs or 350 μs)

Intervention Type: DEVICE

Long Pulse Duration

The holmuim laser device will be used on a long laser pulse duration setting (700 μs or 1500 μs)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cogenix Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Gutierrez-Aceves, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 26585680 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 27960541 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28089885 (View on PubMed)

Other Identifiers

IRB00049526

Identifier Type: -

Identifier Source: org_study_id