Renal StoneNCT06338137
Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment
A study testing Holmium Yag laser in people with Renal Stone, run by Menoufia University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone
- What is being tested?
- Holmium Yag laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- hard renal stones
- less than 2 cm
- Hounsfield unit of ≥ 1000
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Renal Stone
- Being tested
- Holmium Yag laser
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium Yag laserDevice
Use two laser energy low and high to reach the optimal setting for stone dusting
| Study group | Role | What they receive |
|---|---|---|
| high-energy patients | Other | Use high energy in stone management Receives: Device: Holmium Yag laser |
| Low energy patient | Other | Use low energy in stone management Receives: Device: Holmium Yag laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rates
Assess stone free rate between two different setting
Measured: One year
Secondary outcomes (1)
Preoperative complications
To assess complications between low and high energy
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start25 Aug 2022
- Primary completion25 Aug 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Kandeel, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338137
- Sponsor's protocol ID
- 4-2024urol
- Status last verified
- Mar 2024
- First submitted
- 23 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment
- ClinicalTrials.gov ID
- NCT06338137
- Acronym / sponsor ID
- 4-2024urol
- Conditions
- Renal Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-energy patients | Other | Device: Holmium Yag laserUse high energy in stone management |
| Low energy patient | Other | Device: Holmium Yag laserUse low energy in stone management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients
- hard renal stones
- less than 2 cm
- Hounsfield unit of ≥ 1000
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium Yag laserUse two laser energy low and high to reach the optimal setting for stone dusting | Device | Low energy patient, high-energy patients |
Primary outcome
Stone free rates
Time frame: One year
Assess stone free rate between two different setting
1 secondary outcome
Preoperative complications
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium Yag laser in people with Renal Stone, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rates (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.