Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

May 30, 2019 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Short Pulse Duration Group
A short pulse duration (300 μs or 350 μs) will be used in this group.
Device: Short Pulse Duration
The holmium laser device will be used on a short laser pulse duration setting (300 μs or 350 μs)
ACTIVE_COMPARATOR: Long Pulse Duration Group
A long laser pulse duration (700 μs or 1500 μs) will be used in this group.
Device: Long Pulse Duration
The holmuim laser device will be used on a long laser pulse duration setting (700 μs or 1500 μs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: 1 month after surgery
Proportion of participants free of stones after procedure reported by group
1 month after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Cogenix Medical Corporation

Investigators

  • Principal Investigator: Jorge Gutierrez-Aceves, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (ACTUAL)

July 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 3, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00049526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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