Ureteric StoneLASERNCT06975488
Effectiveness of LASER in Treatment of Ureteric Stones.
A study testing LASER Lithotripsy ( Fragmentation modality) and LASER lithotripsy (Dusting Modality) in people with Ureteric Stone, run by District Headquarters Teaching Hospital Sahiwal at 1 site in Pakistan.
Trial summary
Ureteroscopic laser lithotripsy is becoming the most commonly utilized treatment for patients with ureteral stone. The Holmium: YAG laser is integral to the operation and is the preferred flexible intracorporeal lithotripsy. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Ureteric Stone
- What is being tested?
- LASER Lithotripsy ( Fragmentation modality) and LASER lithotripsy (Dusting Modality)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Apr 2024to 20 Apr 2025
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stone size 1cm to 1.5cm at proximal Ureter.
- Patients aged between 15 to 70 years.
- Both genders.
Who cannot join
- Patients with active urinary tract infection
- Pregnancy
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
District Headquarters Teaching Hospital Sahiwal
Sahiwal, Punjab Province, 57000
About this study
Official title: Comparison Between Fragmentation and Dusting Modalities Utilizing Holmium YAG Laser in Ureteroscopy for Ureteral Stone Treatment
Ureteroscopic laser lithotripsy is becoming the most commonly utilized treatment for patients with ureteral stone. The Holmium: YAG laser is integral to the operation and is the preferred flexible intracorporeal lithotripsy. It is considered cost-effective and efficient choice in ureteroscopic lithotripsy on all types of stones. As in recent years, there has been increasing interest in examining the effect of varying the laser settings on the effectiveness of stone treatment. The objective of the study is to compare the fragmentation and dusting modalities utilizing Holmium YAG laser in ureteroscopy for ureteral stone treatment. It will be a randomized control trial (RCT) in which 160 patients visiting Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two groups. Group-A patients will be treated with fragmentation modality utilizing Holmium YAG laser while Group-B patients will be treated with dusting modality utilizing Holmium YAG laser. Simple random sampling technique will be carried out. The patients' age, gender, stone number, stone laterality, stone location, ureteral condition, reteropulsion, stricture formation, stone clearance, operative time, hospital stay, presence of retropulsion and complications will be recorded. Data will be collected through proforma, which will be entered and analyzed using SPSS version 26.0. For quantitative variables such as: age, operation time, hospital stay, stone number ,mean and standard deviation will be calculated and for qualitative variables such as: gender, and laterality, stone location, ureter condition, prevalence of pyuria, stone clearance, presence of retropulsion, ureter injury, frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between study variables. P-value <0.05 will be considered significant. It is anticipated that the results of this study will be helpful for health care planners and surgeons to provide better treatment option to the patients with ureteral stone.
- Conditions
- Ureteric Stone
- Being tested
- LASER Lithotripsy ( Fragmentation modality), LASER lithotripsy (Dusting Modality)
- Keywords
- Laser, URS, DJ Stent, Lithotripsy, ESWL, URSL
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASER Lithotripsy ( Fragmentation modality)Procedure or surgery
Group-A patients will be treated with fragmentation modality utilizing Holmium YAG laser.
LASER lithotripsy (Dusting Modality)Procedure or surgery
Group-B patients will be treated with dusting modality utilizing Holmium YAG laser.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A patients will be treated with fragmentation modality utilizing Holmium YAG laser. Receives: Procedure: LASER Lithotripsy ( Fragmentation modality) |
| Group B | Experimental | Group B patients will be treated with dusting modality utilizing Holmium YAG laser. Receives: Procedure: LASER lithotripsy (Dusting Modality) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Free Rate
Stone-free will be defined as no residual stones > 3 mm in the ureter of the affected side at one month postoperatively on computerized tomography (CT KUB Plain).
Measured: There would be 4 follow up visits. First visit will be after 1 week of URSL and X Ray KUB will be done. Second visit will be after 2 weeks of URSL and we will plan the removal of DJ stent. Those cases in which ureteral inury is suspected or stone burden
Reteropulstion
Retropulsion, defined as unintended migration of stone into the kidney, leads to failure and results in a lower SFR.
Measured: During procedure.
Secondary outcomes (1)
Uretral Stricture Formation
Post-URS ureteral stricture is defined as complete or partial ureteral obstruction as shown by the excretory phase of CTU, which was confirmed with delayed or absent radioactive tracer washout at 8 weeks after stent removal.
Measured: Post-URS ureteral stricture is defined as complete or partial ureteral obstruction as shown by the excretory phase of CTU, which was confirmed with delayed or absent radioactive tracer washout at 8 weeks after stent removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start14 Apr 2024
- Primary completion13 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteric StoneStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- District Headquarters Teaching Hospital Sahiwal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ussama Iftikhar, District Headquarters Teaching Hospital Sahiwal
- Investigators
- U A IFTIHKAR, MS, Principal investigator, District Headquarters Teaching Hospital SahiwalA RIAZ, MD, Study director, Sahiwal medical college sahiwal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975488
- Sponsor's protocol ID
- 195
- Acronym
- LASER
- Status last verified
- May 2025
- First submitted
- 3 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen BH, Lin TF, Tsai CC, Chen M, Chiu AW. Comparison of Fragmentation and Dusting Modality Using Holmium YAG Laser during Ureteroscopy for the Treatment of Ureteral Stone: A Single-Center's Experience. J Clin Med. 2022 Jul 17;11(14):4155. doi: 10.3390/jcm11144155.
PubMed 35887919
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Fragmentation and Dusting Modalities Utilizing Holmium YAG Laser in Ureteroscopy for Ureteral Stone Treatment
- ClinicalTrials.gov ID
- NCT06975488
- Acronym / sponsor ID
- LASER / 195
- Conditions
- Ureteric Stone
- Keywords
- Laser, URS, DJ Stent, Lithotripsy, ESWL, URSL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- District Headquarters Teaching Hospital SahiwalUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 16 May 2025 (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.
Ureteroscopic laser lithotripsy is becoming the most commonly utilized treatment for patients with ureteral stone. The Holmium: YAG laser is integral to the operation and is the preferred flexible intracorporeal lithotripsy. It is considered cost-effective and efficient choice in ureteroscopic lithotripsy on all types of stones. As in recent years, there has been increasing interest in examining the effect of varying the laser settings on the effectiveness of stone treatment. The objective of the study is to compare the fragmentation and dusting modalities utilizing Holmium YAG laser in ureteroscopy for ureteral stone treatment. It will be a randomized control trial (RCT) in which 160 patients visiting Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two groups. Group-A patients will be treated with fragmentation modality utilizing Holmium YAG laser while Group-B patients will be treated with dusting modality utilizing Holmium YAG laser. Simple random sampling technique will be carried out. The patients' age, gender, stone number, stone laterality, stone location, ureteral condition, reteropulsion, stricture formation, stone clearance, operative time, hospital stay, presence of retropulsion and complications will be recorded. Data will be collected through proforma, which will be entered and analyzed using SPSS version 26.0. For quantitative variables such as: age, operation time, hospital stay, stone number ,mean and standard deviation will be calculated and for qualitative variables such as: gender, and laterality, stone location, ureter condition, prevalence of pyuria, stone clearance, presence of retropulsion, ureter injury, frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between study variables. P-value <0.05 will be considered significant. It is anticipated that the results of this study will be helpful for health care planners and surgeons to provide better treatment option to the patients with ureteral stone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: LASER Lithotripsy ( Fragmentation modality)Group A patients will be treated with fragmentation modality utilizing Holmium YAG laser. |
| Group B | Experimental | Procedure: LASER lithotripsy (Dusting Modality)Group B patients will be treated with dusting modality utilizing Holmium YAG laser. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Stone size 1cm to 1.5cm at proximal Ureter.
- Patients aged between 15 to 70 years.
- Both genders.
Key exclusion criteria (3 listed)
- Patients with active urinary tract infection
- Pregnancy
- Immunocompromised patients
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 |
|---|---|---|
| LASER Lithotripsy ( Fragmentation modality)Group-A patients will be treated with fragmentation modality utilizing Holmium YAG laser. | Procedure or surgery | Group A |
| LASER lithotripsy (Dusting Modality)Group-B patients will be treated with dusting modality utilizing Holmium YAG laser. | Procedure or surgery | Group B |
Primary outcome
Stone Free Rate
Time frame: There would be 4 follow up visits. First visit will be after 1 week of URSL and X Ray KUB will be done. Second visit will be after 2 weeks of URSL and we will plan the removal of DJ stent. Those cases in which ureteral inury is suspected or stone burden
Stone-free will be defined as no residual stones > 3 mm in the ureter of the affected side at one month postoperatively on computerized tomography (CT KUB Plain).
Reteropulstion
Time frame: During procedure.
Retropulsion, defined as unintended migration of stone into the kidney, leads to failure and results in a lower SFR.
1 secondary outcome
Uretral Stricture Formation
Time frame: Post-URS ureteral stricture is defined as complete or partial ureteral obstruction as shown by the excretory phase of CTU, which was confirmed with delayed or absent radioactive tracer washout at 8 weeks after stent removal.
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 16 May 2025.
- Results publication: PubMed 35887919Chen BH, Lin TF, Tsai CC, Chen M, Chiu AW. Comparison of Fragmentation and Dusting Modality Using Holmium YAG Laser during Ureteroscopy for the Treatment of Ureteral Stone: A Single-Center's Experience. J Clin Med. 2022 Jul 17;11(14):4155. doi: 10.3390/jcm11144155.
- Laser lithotripsy in treatment of ureteric stonesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
U A IFTIHKAR, MS principal investigator
District Headquarters Teaching Hospital Sahiwal
A RIAZ, MD study director
Sahiwal medical college sahiwal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LASER Lithotripsy ( Fragmentation modality) and LASER lithotripsy (Dusting Modality) in people with Ureteric Stone, run by District Headquarters Teaching Hospital Sahiwal at 1 site in Pakistan.
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 3 inclusion and 3 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 16 May 2025. 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 Pakistan. 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 Rate (time frame: There would be 4 follow up visits. First visit will be after 1 week of URSL and X Ray KUB will be done. Second visit will be after 2 weeks of URSL and we will plan the removal of DJ stent. Those cases in which ureteral inury is suspected or stone burden). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06975488, which also lists 1 linked publication.
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 16 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.