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Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

Primary Purpose

Kidney Stone, Ureter Stone, Renal Stone

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short Pulse Duration
Long Pulse Duration
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring Basketing, Dusting, Holmium Laser, Laser Lithotripsy, Intracorporeal Lithotripsy, Urolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Short Pulse Duration Group

Long Pulse Duration Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Stone free rate
Proportion of participants free of stones after procedure reported by group

Secondary Outcome Measures

Operative duration time
Operative duration time measured by minutes
Need for Secondary Procedures
The number of participants needing additional secondary procedures will be reported per group

Full Information

First Posted
July 24, 2018
Last Updated
May 30, 2019
Sponsor
Wake Forest University Health Sciences
Collaborators
Cogenix Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03608098
Brief Title
Long Pulse Versus Short Pulse Laser Dusting for Renal Stones
Official Title
Long Pulse Versus Short Pulse Laser Dusting for Renal Stones
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Key study team members working on the study are leaving the institution.
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Cogenix Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Ureter Stone, Renal Stone
Keywords
Basketing, Dusting, Holmium Laser, Laser Lithotripsy, Intracorporeal Lithotripsy, Urolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Pulse Duration Group
Arm Type
Active Comparator
Arm Description
A short pulse duration (300 μs or 350 μs) will be used in this group.
Arm Title
Long Pulse Duration Group
Arm Type
Active Comparator
Arm Description
A long laser pulse duration (700 μs or 1500 μs) will be used in this group.
Intervention Type
Device
Intervention Name(s)
Short Pulse Duration
Intervention Description
The holmium laser device will be used on a short laser pulse duration setting (300 μs or 350 μs)
Intervention Type
Device
Intervention Name(s)
Long Pulse Duration
Intervention Description
The holmuim laser device will be used on a long laser pulse duration setting (700 μs or 1500 μs)
Primary Outcome Measure Information:
Title
Stone free rate
Description
Proportion of participants free of stones after procedure reported by group
Time Frame
1 month after surgery
Secondary Outcome Measure Information:
Title
Operative duration time
Description
Operative duration time measured by minutes
Time Frame
1 month after surgery
Title
Need for Secondary Procedures
Description
The number of participants needing additional secondary procedures will be reported per group
Time Frame
1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Gutierrez-Aceves, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
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PubMed Identifier
26585680
Citation
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.
Results Reference
background
PubMed Identifier
29061070
Citation
Matlaga BR, Chew B, Eisner B, Humphreys M, Knudsen B, Krambeck A, Lange D, Lipkin M, Miller NL, Monga M, Pais V, Sur RL, Shah O. Ureteroscopic Laser Lithotripsy: A Review of Dusting vs Fragmentation with Extraction. J Endourol. 2018 Jan;32(1):1-6. doi: 10.1089/end.2017.0641. Epub 2017 Nov 27.
Results Reference
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PubMed Identifier
27960541
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.
Results Reference
background
PubMed Identifier
28089885
Citation
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.
Results Reference
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Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

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