Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

NCT03608098 | Withdrawn FDA Device

• 1 other identifier: IRB00049526
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone; Ureter Stone; Renal Stone

Keywords

Basketing; Dusting; Holmium Laser; Laser Lithotripsy; Intracorporeal Lithotripsy; Urolithiasis

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  Proportion of participants free of stones after procedure reported by group

  1 month after surgery

Secondary Outcomes (2)

• Operative duration time

  1 month after surgery

• Need for Secondary Procedures

  1 month after surgery

Study Arms (2)

Short Pulse Duration Group

ACTIVE COMPARATOR

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

Device: Short Pulse Duration

Long Pulse Duration Group

ACTIVE COMPARATOR

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

Device: Long Pulse Duration

Interventions

Short Pulse Duration DEVICE

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

Short Pulse Duration Group

Long Pulse Duration DEVICE

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

Long Pulse Duration Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Solitary Kidney
• Age under 18
• Pregnancy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Cogenix Medical Corporation: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

• 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.

  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.

  PMID: 26585680 BACKGROUND

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

  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.

  PMID: 27960541 BACKGROUND

• 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.

  PMID: 28089885 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Ureterolithiasis; Nephrolithiasis; Urolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases

Study Officials

• Jorge Gutierrez-Aceves, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects enrolled in the study will be randomized to either short pulse or long pulse for treatment of their stones. The date of treatment will be decided between the subject and the treating surgeon. All treatments will be performed using the standard of care and will be performed in the same fashion as procedures for patients not enrolled in the study. There is no modification of the techniques used to remove the stones. Post operatively, we plan to discharge all subjects home from the recovery unit. All subjects will be seen one week to one month after surgery for stent removal and a low dose CT of the abdomen and pelvis to assess stone free rates which is standard for all stone patients.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: July 31, 2018
• Study Start: May 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: June 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)