NCT06338137

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

April 4, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 23, 2024

Last Update Submit

April 3, 2024

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

  • Stone free rates

    Assess stone free rate between two different setting

    One year

Secondary Outcomes (1)

  • Preoperative complications

    One year

Study Arms (2)

high-energy patients

OTHER

Use high energy in stone management

Device: Holmium Yag laser

Low energy patient

OTHER

Use low energy in stone management

Device: Holmium Yag laser

Interventions

Holmium Yag laserDEVICE

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

Low energy patienthigh-energy patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hossam Kandeel

Shibīn al Kawm, State Or Province, 32511, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 23, 2024

First Posted

March 29, 2024

Study Start

August 25, 2022

Primary Completion

August 25, 2023

Study Completion

January 1, 2024

Last Updated

April 4, 2024

Record last verified: 2024-03

Locations

EG(1)