Kidney CalculiNCT06667557
Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy
An observational study of Kidney Calculi, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this prospective, multicenter, randomized controlled trial is to objectively evaluate the clinical efficacy and safety differences between superpulse thulium fiber laser (sTFL) and holmium:YAG laser (Ho:YAG) in flexible ureteroscopy (FURS) lithotripsy in adult patients aged 18-70 years with kidney stones… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Superpulse Thulium Fiber Laser (sTFL) Treatment and Holmium:YAG Laser (Ho:YAG) Treatment
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 20 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-70 years who plan to undergo fURS lithotripsy for kidney stones and/or upper ureteral stones (6-20mm)
Who may be able to join
- Age ≥18 years old
- Diagnosis of kidney stones and/or upper ureteral stones with stone diameter ≥6mm and ≤20mm
- Plan to undergo fURS lithotripsy
- General anesthesia to complete the operation
- The latest urine culture before surgery is negative
- Signed and dated informed consent indicating that the patient or his or her legal representative has been fully informed about the study and has consented to participate
Who cannot join
- Isolated kidney
- Previous history of kidney transplantation or urinary diversion surgery
- Congenital malformations of urinary system
- Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc.
- Severe heart or lung disease, malignancy and immune deficiency status
- Neurogenic bladder
Show all 13Show fewer
- Failure to provide informed consent
- Have an untreated urinary tract infection
- The presence of known anatomic abnormalities (such as ureteral stenosis), urothelial tumors, or stones that can be removed directly without the use of laser lithotripsy
- Pregnant women
- In cases where the stone cannot be reached with a bendable negative pressure suction sheath, or in cases where the stone cannot be reached with a conventional sheath or the pyeloureteral junction
- Surgical completion under epidural anesthesia or lumbar anesthesia
- Recurrent stones due to genetic metabolic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 201620
Yi Shao, Doctor, 18861968196 ext. 86
About this study
Official title: Comparison of Super Pulse Fiber Thulium Laser and Holmium Laser Lithotripsy Under Ureteroscopy
The goal of this prospective, multicenter, randomized controlled trial is to objectively evaluate the clinical efficacy and safety differences between superpulse thulium fiber laser (sTFL) and holmium:YAG laser (Ho:YAG) in flexible ureteroscopy (FURS) lithotripsy in adult patients aged 18-70 years with kidney stones and/or upper ureteral stones (6-20mm). The main questions it aims to answer are:
Does sTFL yield a higher stone-free rate (SFR) compared to Ho:YAG at 3 months post-FURS? Is sTFL superior to Ho:YAG in terms of operation time, complication rate, and surgeon's visual experience during FURS? Researchers will compare the experimental group receiving sTFL treatment to the control group receiving Ho:YAG laser treatment to see if sTFL demonstrates better lithotripsy efficiency, safety, and ease of operation.
Read more
Participants aged 18-70 years will:
Undergo FURS lithotripsy under general anesthesia using either sTFL (experimental group) or Ho:YAG laser (control group) based on randomization Have CT scans at 3 months post-operation to assess stone-free status Be monitored for intraoperative and postoperative complications Have surgeons rate their visual experience during the procedure in terms of visual clarity, lithotripsy efficiency, stone movement and tissue injury
Read the detailed description
Flexible ureteroscopy (FURS) has become a widely accepted minimally invasive treatment modality for kidney stones and upper ureteral stones. Holmium:YAG laser (Ho:YAG) is currently the gold standard for laser lithotripsy during FURS. However, the superpulse thulium fiber laser (sTFL) has emerged as a promising alternative with potential advantages in terms of lithotripsy efficiency and safety. This prospective, multicenter, randomized controlled trial aims to objectively evaluate the clinical efficacy and safety differences between sTFL and Ho:YAG in FURS for adult patients with kidney stones and/or upper ureteral stones (6-20mm).
The study will enroll 136 participants aged 18-70 years with confirmed diagnosis of kidney stones and/or upper ureteral stones (6-20mm) based on CT scans. Participants will be randomized in a 1:1 ratio to undergo FURS with either sTFL (experimental group) or Ho:YAG (control group). The primary outcome measure will be the stone-free rate (SFR) at 3 months post-operation, defined as residual fragments <2mm on CT scans. Secondary outcomes will include operation time, intraoperative complications (e.g., ureteral injury, bleeding, infection), postoperative complications (e.g., fever, hematuria), changes in vital signs, surgeon's visual experience, and stone recurrence rate at 6 months.
Participants will be closely monitored for adverse events and complications throughout the study period. The Clavien-Dindo classification system will be used to grade postoperative complications. Detailed safety assessments will be performed, including recording of adverse events, reporting of serious adverse events, monitoring of vital signs, and evaluation of complications.
The study will consist of the following visits:
Baseline visit (screening period): Participants will provide informed consent, undergo eligibility assessment, and have their demographic information, medical history, vital signs, and CT scans collected.
Intraoperative visit (treatment period): Researchers will record operation time, laser type used, surgeon's visual experience, and monitor vital signs and complications.
Postoperative visits (treatment period): Participants will be closely monitored for vital signs, symptoms, and complications within 24 hours after surgery.
Follow-up visits at 3 months and 6 months (follow-up period): Participants will undergo CT scans to assess stone clearance and recurrence.
- Conditions
- Kidney Calculi
- Being tested
- Superpulse Thulium Fiber Laser (sTFL) Treatment, Holmium:YAG Laser (Ho:YAG) Treatment
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superpulse Thulium Fiber Laser (sTFL) TreatmentDevice
The superpulse thulium fiber laser (sTFL) was used as a minimally invasive surgical treatment for kidney and upper ureteral stones. All procedures were performed by experienced urologists using standard techniques for laser lithotripsy. Laser settings, such as pulse energy and frequency, were adjusted according to stone characteristics and the surgeon's judgment to optimize treatment efficacy and safety.
Holmium:YAG Laser (Ho:YAG) TreatmentDevice
The holmium:YAG laser (Ho:YAG) was used as a minimally invasive surgical treatment for kidney and upper ureteral stones. All procedures were performed by experienced urologists using standard techniques for laser lithotripsy. Laser settings, such as pulse energy and frequency, were adjusted according to stone characteristics and the surgeon's judgment to optimize treatment efficacy and safety.
| Study group | Role | What they receive |
|---|---|---|
| sTFL Group | Kidney stones and/or upper ureteral stones are treated with a superpulsed thulium fiber laser (sTFL) Receives: Device: Superpulse Thulium Fiber Laser (sTFL) Treatment | |
| Ho:YAG Group | Kidney stones and/or upper ureteral stones are treated with a holmium :YAG laser (Ho:YAG) Receives: Device: Holmium:YAG Laser (Ho:YAG) Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free Rate
The proportion of participants achieving complete stone clearance, defined as no residual fragments or residual fragments ≤2 mm on follow-up imaging (e.g., plain radiography, ultrasound, or computed tomography) after a single laser lithotripsy procedure.
Measured: 3 months post-procedure
Secondary outcomes (3)
Operative Time
The duration of the surgical procedure, measured in minutes from the start of the operation until the completion of the surgical procedure. Operative times will be recorded and compared between the two groups.
Measured: Measured during the procedure
Complication Rate
The proportion of participants experiencing complications during the surgical procedure and within 24 hours after the procedure. Complications will be recorded and classified according to the Clavien-Dindo system, which categorizes surgical complications by severity. The complication rates will be compared between the two groups.
Measured: From the start of the procedure until 24 hours post-procedure
Surgeon's Visual Experience
The surgeon's subjective assessment of visual clarity, stone fragmentation efficiency, stone movement, and tissue damage during the procedure. Recording the subjective feelings of urologists.
Measured: Measured immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start20 Jan 2025
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Shao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yi Shao, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667557
- Sponsor's protocol ID
- IIT2024-147
- Status last verified
- Jan 2026
- First submitted
- 30 Oct 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Super Pulse Fiber Thulium Laser and Holmium Laser Lithotripsy Under Ureteroscopy
- ClinicalTrials.gov ID
- NCT06667557
- Acronym / sponsor ID
- IIT2024-147
- Conditions
- Kidney Calculi
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 31 Oct 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.
The goal of this prospective, multicenter, randomized controlled trial is to objectively evaluate the clinical efficacy and safety differences between superpulse thulium fiber laser (sTFL) and holmium:YAG laser (Ho:YAG) in flexible ureteroscopy (FURS) lithotripsy in adult patients aged 18-70 years with kidney stones and/or upper ureteral stones (6-20mm). The main questions it aims to answer are:
Does sTFL yield a higher stone-free rate (SFR) compared to Ho:YAG at 3 months post-FURS? Is sTFL superior to Ho:YAG in terms of operation time, complication rate, and surgeon's visual experience during FURS? Researchers will compare the experimental group receiving sTFL treatment to the control group receiving Ho:YAG laser treatment to see if sTFL demonstrates better lithotripsy efficiency, safety, and ease of operation.
Participants aged 18-70 years will:
Undergo FURS lithotripsy under general anesthesia using either sTFL (experimental group) or Ho:YAG laser (control group) based on randomization Have CT scans at 3 months post-operation to assess stone-free status Be monitored for intraoperative and postoperative complications Have surgeons rate their visual experience during the procedure in terms of visual clarity, lithotripsy efficiency, stone movement and tissue injury
Detailed description
Flexible ureteroscopy (FURS) has become a widely accepted minimally invasive treatment modality for kidney stones and upper ureteral stones. Holmium:YAG laser (Ho:YAG) is currently the gold standard for laser lithotripsy during FURS. However, the superpulse thulium fiber laser (sTFL) has emerged as a promising alternative with potential advantages in terms of lithotripsy efficiency and safety. This prospective, multicenter, randomized controlled trial aims to objectively evaluate the clinical efficacy and safety differences between sTFL and Ho:YAG in FURS for adult patients with kidney stones and/or upper ureteral stones (6-20mm).
The study will enroll 136 participants aged 18-70 years with confirmed diagnosis of kidney stones and/or upper ureteral stones (6-20mm) based on CT scans. Participants will be randomized in a 1:1 ratio to undergo FURS with either sTFL (experimental group) or Ho:YAG (control group). The primary outcome measure will be the stone-free rate (SFR) at 3 months post-operation, defined as residual fragments <2mm on CT scans. Secondary outcomes will include operation time, intraoperative complications (e.g., ureteral injury, bleeding, infection), postoperative complications (e.g., fever, hematuria), changes in vital signs, surgeon's visual experience, and stone recurrence rate at 6 months.
Participants will be closely monitored for adverse events and complications throughout the study period. The Clavien-Dindo classification system will be used to grade postoperative complications. Detailed safety assessments will be performed, including recording of adverse events, reporting of serious adverse events, monitoring of vital signs, and evaluation of complications.
The study will consist of the following visits:
Baseline visit (screening period): Participants will provide informed consent, undergo eligibility assessment, and have their demographic information, medical history, vital signs, and CT scans collected.
Intraoperative visit (treatment period): Researchers will record operation time, laser type used, surgeon's visual experience, and monitor vital signs and complications.
Postoperative visits (treatment period): Participants will be closely monitored for vital signs, symptoms, and complications within 24 hours after surgery.
Follow-up visits at 3 months and 6 months (follow-up period): Participants will undergo CT scans to assess stone clearance and recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sTFL Group | – | Device: Superpulse Thulium Fiber Laser (sTFL) TreatmentKidney stones and/or upper ureteral stones are treated with a superpulsed thulium fiber laser (sTFL) |
| Ho:YAG Group | – | Device: Holmium:YAG Laser (Ho:YAG) TreatmentKidney stones and/or upper ureteral stones are treated with a holmium :YAG laser (Ho:YAG) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-70 years who plan to undergo fURS lithotripsy for kidney stones and/or upper ureteral stones (6-20mm)
Key inclusion criteria (6 listed)
- Age ≥18 years old
- Diagnosis of kidney stones and/or upper ureteral stones with stone diameter ≥6mm and ≤20mm
- Plan to undergo fURS lithotripsy
- General anesthesia to complete the operation
- The latest urine culture before surgery is negative
Key exclusion criteria (13 listed)
- Isolated kidney
- Previous history of kidney transplantation or urinary diversion surgery
- Congenital malformations of urinary system
- Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc.
- Severe heart or lung disease, malignancy and immune deficiency status
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 |
|---|---|---|
| Superpulse Thulium Fiber Laser (sTFL) TreatmentThe superpulse thulium fiber laser (sTFL) was used as a minimally invasive surgical treatment for kidney and upper ureteral stones. All procedures were performed by experienced urologists using standard techniques for laser lithotripsy. Laser settings, such as pulse energy and frequency, were adjusted according to stone characteristics and the surgeon's judgment to optimize treatment efficacy and safety. | Device | sTFL Group |
| Holmium:YAG Laser (Ho:YAG) TreatmentThe holmium:YAG laser (Ho:YAG) was used as a minimally invasive surgical treatment for kidney and upper ureteral stones. All procedures were performed by experienced urologists using standard techniques for laser lithotripsy. Laser settings, such as pulse energy and frequency, were adjusted according to stone characteristics and the surgeon's judgment to optimize treatment efficacy and safety. | Device | Ho:YAG Group |
Primary outcome
Stone-free Rate
Time frame: 3 months post-procedure
The proportion of participants achieving complete stone clearance, defined as no residual fragments or residual fragments ≤2 mm on follow-up imaging (e.g., plain radiography, ultrasound, or computed tomography) after a single laser lithotripsy procedure.
3 secondary outcomes
Operative Time
Time frame: Measured during the procedure
Complication Rate
Time frame: From the start of the procedure until 24 hours post-procedure
Surgeon's Visual Experience
Time frame: Measured immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- 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.
Yi Shao principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Calculi, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 13 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruixuan Zhu (+86 13780820139, luluzhu2023@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free Rate (time frame: 3 months post-procedure). 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 21 Jan 2026.