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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06338137
Other study ID # 4-2024urol
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 25, 2022
Est. completion date January 1, 2024

Study information

Verified date March 2024
Source Menoufia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date January 1, 2024
Est. primary completion date August 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients - hard renal stones - less than 2 cm - Hounsfield unit of = 1000 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Holmium Yag laser
Use two laser energy low and high to reach the optimal setting for stone dusting

Locations

Country Name City State
Egypt Hossam Kandeel Shibin Al Kawm State Or Province

Sponsors (1)

Lead Sponsor Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stone free rates Assess stone free rate between two different setting One year
Secondary Preoperative complications To assess complications between low and high energy One year
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