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CompletedNCT06338137Updated Apr 4, 2024

Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment

An interventional study of Holmium Yag laser in Renal Stone, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Menoufia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Aug 2022, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Rcompare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy.

Read the detailed description

The prevalence of urinary stone disease treatment has shown a continuous updating Within the armamentarium of urinary stone management, the laser has emerged as a cornerstone for lithotripsy in endourological procedures. The laser technology has witnessed a progressive evolution, transitioning from the established holmium: yttrium-aluminum-garnet (Ho:YAG) laser with pulse modulation to the advent of thulium fiber laser (TFL) and, more recently, the innovative pulsed thulium:YAG (p-Tm:YAG) laser Laser lithotripsy is prefered for its minimally invasive approach and high success rates in fragmenting stones, yet the ongoing debate continues regarding the optimal laser power settings for this procedure. contemporary approaches in laser lithotripsy focus on two primary strategies: fragmenting stones into smaller retrievable parts or breaking them into minute fragments, commonly referred to as 'dust,' facilitating the natural passage of smaller particles The choice between high power and low power settings in laser lithotripsy significantly influences treatment outcomes, including stone fragmentation efficiency, procedural time, and potential tissue damage. High-energy power laser settings offer rapid stone ablation capabilities, enabling quick fragmentation but potentially raising concerns about thermal injury to surrounding tissues. In contrast, low-energy power settings, while reducing the risk of tissue damage, might prolong the procedure and necessitate additional maneuvers for complete stone clearance This study aims to compare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy. By scrutinizing existing literature and recent studies, this study intends to provide a 56 comprehensive understanding of the clinical implications of choosing optimal laser settings in urolithiasis comprehensive understanding of the clinical implications of choosing optimal laser settings in urolithiasis.

02

Conditions studied

  • Renal Stone

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03

In context

Nephrolithiasis

467 studies on the registry are indexed under Nephrolithiasis; 108 are open to participants now.

This study's enrollment of 160 is above the median of 90 across 365 interventional studies indexed under Nephrolithiasis.

Browse Nephrolithiasis studies →

Lead sponsor

Menoufia University is the lead sponsor of 197 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult patients
  • hard renal stones
  • less than 2 cm
  • Hounsfield unit of ≥ 1000

Exclusion criteria

Exclusion Criteria:

  • Patients less than 18 years
  • ureteral stones
  • stones with Hounsfield units less than 1000
  • stones in calyceal diverticulum
  • patients with coagulopathy were also excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Other
    high-energy patients

    Use high energy in stone management

    Device: Holmium Yag laser

  • Other
    Low energy patient

    Use low energy in stone management

    Device: Holmium Yag laser

Interventions

  • DeviceHolmium Yag laser

    Use two laser energy low and high to reach the optimal setting for stone dusting

06

What researchers measure

Primary outcomes

  1. Stone free rates

    Assess stone free rate between two different setting

    Time frame: One year

Secondary outcomes

  1. Preoperative complications

    To assess complications between low and high energy

    Time frame: One year

07

Study locations

1 site
  • Hossam Kandeel
    Shibīn al Kawm, State Or Province 32511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06338137
Responsible party
Hossam Kandeel (Director, Menoufia University) — Principal investigator
First posted
Mar 29, 2024
Start date
Aug 25, 2022
Primary completion
Aug 25, 2023
Completion
Jan 1, 2024
Last update
Apr 4, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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