Urinary CalculiNCT05048706
SP TLF Versus Ho:YAG Laser
An observational study of Urinary Calculi, run by University of Rochester at 2 sites in United States.
Trial summary
The investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Calculi
- What is being tested?
- Laser lithotripsy (SP TLF) and Laser lithotripsy (Ho:YAG)
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2021to 1 Jan 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects eligible for this study will be identified via eRecord in the Urology Department (routine access) of patients who were diagnosed with upper urinary tract calculi who underwent surgery utilizing either high powered Ho:YAG or TL-SPL lasers.
Who may be able to join
- Patient is scheduled to undergo mini-PCNL and/or RIRS surgery at the University of Rochester Medical Center for the management of upper urinary tract calculi (i.e. kidney and proximal ureter)
- Stones located in the kidney and proximal ureter
- Stones measuring 10-30mm
- Ability to give informed consent
- Any racial or ethnic origin
- Age 18 years and older
Who cannot join
- Active kidney infection
- Patients with prior stenting
- Pregnant patients
- Patients with solitary kidney
- Patients with ureteral tumor or stricture
- Inability to give informed consent
- Not age 18 and older
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Rochester Medical Center
Rochester, New York, 14642
University of Rochester
Rochester, New York, 14642
About this study
Official title: Comparative Effectiveness of the Super Pulse Thulium Fiber Laser (SP TLF) for Laser Lithotripsy of Urinary Calculi
The investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters leading to more efficient (4 times more) and effective stone dusting resulting in production of finer dust particles obviating the need for postoperative ureteric stenting which remains a major source of patient discomfort.
- Conditions
- Urinary Calculi
- Being tested
- Laser lithotripsy (SP TLF), Laser lithotripsy (Ho:YAG)
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser lithotripsy (SP TLF)Device
Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)
Laser lithotripsy (Ho:YAG)Device
Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.
| Study group | Role | What they receive |
|---|---|---|
| Super Pulse Thulium fiber Laser | Not described Receives: Device: Laser lithotripsy (SP TLF) | |
| Holmium: Yttrium-Aluminium-Garnet Laser | Not described Receives: Device: Laser lithotripsy (Ho:YAG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficiency of SP TFL in dusting stones
We plan to assess the direct impact of SP TFL to efficiently dust 10-30mm stones in the upper urinary tract . Metrics include time needed to ablate the stone i.e. ablation speed (stone volume mm3/sec)
Measured: 6 months
Mean ablation energy needed to ablate stone volume
We plan to assess the direct impact of SP TFL to effectively dust 10-30mm stones in the upper urinary tract . Metrics include ablation energy needed to ablate the stone volume (Stone volume mm3/Joules)
Measured: 6 months
Secondary outcomes (2)
Number of stones cleared.
We plan to assess the direct impact of SP TFL to produce finer quality dust following disregarding of 10-30mm stones in the upper urinary tract that can spontaneously pass without the need for stenting . Metrics will be stone clearance on postoperative CT scans
Measured: 9 months
Number of participants reporting complications.
We plan to assess the direct impact of SP TFL to safely dust 10-30mm stones in the upper urinary tract . Metrics collected will include review of medical record for the presence of complications (e.g. infection, sepsis, obstruction etc.) for 3 months postoperative related to laser lithotripsy.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start10 May 2021
- Primary completion1 Jan 2024
- 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 Urinary CalculiStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Ghazi, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048706
- Sponsor's protocol ID
- STUDY00005201
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2021
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of the Super Pulse Thulium Fiber Laser (SP TLF) for Laser Lithotripsy of Urinary Calculi
- ClinicalTrials.gov ID
- NCT05048706
- Acronym / sponsor ID
- STUDY00005201
- Conditions
- Urinary Calculi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Sep 2021 (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 investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters leading to more efficient (4 times more) and effective stone dusting resulting in production of finer dust particles obviating the need for postoperative ureteric stenting which remains a major source of patient discomfort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super Pulse Thulium fiber Laser | – | Device: Laser lithotripsy (SP TLF) |
| Holmium: Yttrium-Aluminium-Garnet Laser | – | Device: Laser lithotripsy (Ho:YAG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects eligible for this study will be identified via eRecord in the Urology Department (routine access) of patients who were diagnosed with upper urinary tract calculi who underwent surgery utilizing either high powered Ho:YAG or TL-SPL lasers.
Key inclusion criteria (6 listed)
- Patient is scheduled to undergo mini-PCNL and/or RIRS surgery at the University of Rochester Medical Center for the management of upper urinary tract calculi (i.e. kidney and proximal ureter)
- Stones located in the kidney and proximal ureter
- Stones measuring 10-30mm
- Ability to give informed consent
- Any racial or ethnic origin
Key exclusion criteria (7 listed)
- Active kidney infection
- Patients with prior stenting
- Pregnant patients
- Patients with solitary kidney
- Patients with ureteral tumor or stricture
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 (SP TLF)Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF) | Device | Super Pulse Thulium fiber Laser |
| Laser lithotripsy (Ho:YAG)Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. | Device | Holmium: Yttrium-Aluminium-Garnet Laser |
Primary outcome
To determine the efficiency of SP TFL in dusting stones
Time frame: 6 months
We plan to assess the direct impact of SP TFL to efficiently dust 10-30mm stones in the upper urinary tract . Metrics include time needed to ablate the stone i.e. ablation speed (stone volume mm3/sec)
Mean ablation energy needed to ablate stone volume
Time frame: 6 months
We plan to assess the direct impact of SP TFL to effectively dust 10-30mm stones in the upper urinary tract . Metrics include ablation energy needed to ablate the stone volume (Stone volume mm3/Joules)
2 secondary outcomes
Number of stones cleared.
Time frame: 9 months
Number of participants reporting complications.
Time frame: 9 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 24 Mar 2025.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
Related trials for Urinary Calculi
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Not yet recruiting
Ureteral Access Strategies in Retrograde Intrarenal Surgery
Nephrolithiasis, Kidney Calculi
RecruitingEarly Phase 1
Fecal Microbiota Transplantation in Kidney Stone Patients
Kidney Stones, Urinary Stone Disease / Nephrolithiasis
RecruitingObservational study
Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
Kidney Calculi, Nephrolithiasis
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.
Ahmed Ghazi, MD principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Calculi, run by University of Rochester at 2 sites in United States.
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 6 inclusion and 7 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
To determine the efficiency of SP TFL in dusting stones (time frame: 6 months). 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?
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 24 Mar 2025.