Renal StonesRIRS and TFLNCT07153978
Safety of Thulium Fiber Laser Litothripsy in the Management of Large Renal Stones (>1000 mm³) and Factors Affecting Treatment Success
A study testing Effectivity of TFL on large renal stone in people with Renal Stones and Retrograde Intrarenal Surgery, run by Muharrem Baturu at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the efficacy and safety of Thulium Fiber Laser (TFL) litothripsy according to stone density and the factors affecting success in patients undergoing retrograde intrarenal surgery (RIRS) for renal calculi >1000 mm3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones, Retrograde Intrarenal Surgery, Thulium Fiber Laser
- What is being tested?
- Effectivity of TFL on large renal stone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age
- Presence of kidney stones larger than 1000 mm³
- Patients with single or multiple kidney stones
- Patients eligible for retrograde intrarenal surgery (RIRS)
Who cannot join
- Patients younger than 18 years
- Pregnant or breastfeeding women
- Patients with uncorrected coagulopathy
- Patients with active urinary tract infection
- Patients with severe anatomic abnormalities preventing RIRS
- Patients unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Gaziantep
Gaziantep, Şehitkamil, 27310
About this study
Official title: Safety of Thulium Fiber Laser Litothripsy in the Management of Large Renal Stones (>1000 mm³) and Factors Affecting Treatment Success:
The aim of this study is to compare the efficacy and safety of Thulium Fiber Laser (TFL) litothripsy according to stone density and the factors affecting success in patients undergoing retrograde intrarenal surgery (RIRS) for renal calculi >1000 mm3. Between November 2023 and December 2024, 81 patients with a stone volume >1000 mm3 who underwent RIRS with TFL in our clinic were prospectively and sequentially evaluated. Stone density of the patients was measured, and expressed in Hounsfield Units (HU). Patients with stone densities <1000 HU and ≥1000 HU were categorized as Groups 1, and 2, respectively. Demographic data, data of intraoperative laser use, stone-free rates (SFRs), the need for a second session of RIRS and complications were recorded. Duration of TFL litothripsy, total energy used, laser ablation speed (mm3/sec), laser ablation efficiency (mm3/J) and laser energy consumption (J/mm3) were calculated. Correlation tests, univariate and multivariate logistic regression tests were used for statistical analysis.
- Being tested
- Effectivity of TFL on large renal stone
- Keywords
- Retrograde intrarenal surgery,, Thulium fiber laser, Stone free rate, Kidney stone, Hounsfield Unit.
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effectivity of TFL on large renal stoneDevice
While literature studies on TFL have focused on the effect of stone size on laser efficacy parameters, the present study is important as it is a prospective study examining the effects of TFL lithotripsy on SFRs in stones >1000 mm3.
| Study group | Role | What they receive |
|---|---|---|
| Safety and Efficacy of Thulium Fiber Laser for Large Renal Stones | Experimental | Demographic data (age, gender, body mass index (BMI)), stone characteristics (size, location, Hounsfield Unit (HU) value) and durations of the procedures were recorded. Patients over 18 years of age, with kidney stones larger than 1000 mm³, single or multiple stones and those eligible for RIRS were included in the study. Patients under 18 years of age, those with bleeding diathesis or inability to discontinue anticoagulant/antiaggregant therapy, cases with a history of previous RIRS, individuals who did not attend follow-up visits, patients in whom postoperative residual stone assessment could not be made, or had concomitant bladder or ureteral stones were excluded. SFRs, the need for a second session of RIRS and complications were noted. General anesthesia was used. Rigid ureteroscope was inserted through urethral meatus. 11/13 F ureteral sheath was advanced over guidewire under fluoroscopy. Laser settings varied 0.2J/100Hz to 1J/10Hz based on stone fragility. Receives: Device: Effectivity of TFL on large renal stone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was to assess the effectiveness of the laser.
Fragmentation success was used to evaluate the laser effectiveness of laser.
Measured: 12 months
Secondary outcomes (1)
The secondary outcome was the evaluation of factors affecting stone-free rates
A residual fragment of ≤2 mm was considered stone-free. The unit of measure for all parameters was the percentage of patients stone-free.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Nov 2023
- Primary completion1 Dec 2024
- Study completion1 Jun 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 Renal StonesStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muharrem Baturu
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gaziantep
- Responsible party
- Sponsor-investigator, Muharrem Baturu, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153978
- Sponsor's protocol ID
- 2023/06
- Other IDs
- TF.ALT.23.10
- Acronym
- RIRS and TFL
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Baturu M, Seckiner I, Bayrak O, Kirac M, Ozturk M, Erturhan S. Efficacy of thulium fiber laser litothripsy on large renal stones (> 1000 mm(3)) according to Hounsfield units: a prospective single-center study. BMC Urol. 2026 Apr 1;26(1):122. doi: 10.1186/s12894-026-02138-w.
PubMed 41923045
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Thulium Fiber Laser Litothripsy in the Management of Large Renal Stones (>1000 mm³) and Factors Affecting Treatment Success:
- ClinicalTrials.gov ID
- NCT07153978
- Acronym / sponsor ID
- RIRS and TFL / 2023/06
- Keywords
- Retrograde intrarenal surgery,, Thulium fiber laser, Stone free rate, Kidney stone, Hounsfield Unit.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Muharrem BaturuUniversity, hospital or other
- Collaborators
- University of Gaziantep
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Sep 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.
The aim of this study is to compare the efficacy and safety of Thulium Fiber Laser (TFL) litothripsy according to stone density and the factors affecting success in patients undergoing retrograde intrarenal surgery (RIRS) for renal calculi >1000 mm3. Between November 2023 and December 2024, 81 patients with a stone volume >1000 mm3 who underwent RIRS with TFL in our clinic were prospectively and sequentially evaluated. Stone density of the patients was measured, and expressed in Hounsfield Units (HU). Patients with stone densities <1000 HU and ≥1000 HU were categorized as Groups 1, and 2, respectively. Demographic data, data of intraoperative laser use, stone-free rates (SFRs), the need for a second session of RIRS and complications were recorded. Duration of TFL litothripsy, total energy used, laser ablation speed (mm3/sec), laser ablation efficiency (mm3/J) and laser energy consumption (J/mm3) were calculated. Correlation tests, univariate and multivariate logistic regression tests were used for statistical analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety and Efficacy of Thulium Fiber Laser for Large Renal Stones | Experimental | Device: Effectivity of TFL on large renal stoneDemographic data (age, gender, body mass index (BMI)), stone characteristics (size, location, Hounsfield Unit (HU) value) and durations of the procedures were recorded. Patients over 18 years of age, with kidney stones larger than 1000 mm³, single or multiple stones and those eligible for RIRS were included in the study. Patients under 18 years of age, those with bleeding diathesis or inability to discontinue anticoagulant/antiaggregant therapy, cases with a history of previous RIRS, individuals who did not attend follow-up visits, patients in whom postoperative residual stone assessment could not be made, or had concomitant bladder or ureteral stones were excluded. SFRs, the need for a second session of RIRS and complications were noted. General anesthesia was used. Rigid ureteroscope was inserted through urethral meatus. 11/13 F ureteral sheath was advanced over guidewire under fluoroscopy. Laser settings varied 0.2J/100Hz to 1J/10Hz based on stone fragility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥18 years of age
- Presence of kidney stones larger than 1000 mm³
- Patients with single or multiple kidney stones
- Patients eligible for retrograde intrarenal surgery (RIRS)
Key exclusion criteria (6 listed)
- Patients younger than 18 years
- Pregnant or breastfeeding women
- Patients with uncorrected coagulopathy
- Patients with active urinary tract infection
- Patients with severe anatomic abnormalities preventing RIRS
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 |
|---|---|---|
| Effectivity of TFL on large renal stoneWhile literature studies on TFL have focused on the effect of stone size on laser efficacy parameters, the present study is important as it is a prospective study examining the effects of TFL lithotripsy on SFRs in stones >1000 mm3. | Device | Safety and Efficacy of Thulium Fiber Laser for Large Renal Stones |
Primary outcome
The primary outcome was to assess the effectiveness of the laser.
Time frame: 12 months
Fragmentation success was used to evaluate the laser effectiveness of laser.
1 secondary outcome
The secondary outcome was the evaluation of factors affecting stone-free rates
Time frame: 3 months
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 Sep 2025.
- Derived from this study: PubMed 41923045Baturu M, Seckiner I, Bayrak O, Kirac M, Ozturk M, Erturhan S. Efficacy of thulium fiber laser litothripsy on large renal stones (> 1000 mm(3)) according to Hounsfield units: a prospective single-center study. BMC Urol. 2026 Apr 1;26(1):122. doi: 10.1186/s12894-026-02138-w.
- Individual participant dataSharing planned: Yes
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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 Effectivity of TFL on large renal stone in people with Renal Stones and Retrograde Intrarenal Surgery, run by Muharrem Baturu at 1 site in Turkey (Türkiye).
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 6 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 Sep 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 Turkey (Türkiye). 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?
The primary outcome was to assess the effectiveness of the laser. (time frame: 12 months). 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 NCT07153978, 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 4 Sep 2025.