UrolithiasisNCT06489366
Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial
A study testing Thulium Fiber laser (TFL) lithotripsy and Ho: YAG lithotripsy in people with Urolithiasis and Proximal Ureteral Stone, run by Zhongnan Hospital at 1 site in China.
Trial summary
The efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Proximal Ureteral Stone
- What is being tested?
- Thulium Fiber laser (TFL) lithotripsy and Ho: YAG lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2024to 26 Feb 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
- ≥18 years old;
- patients diagnosed with unilateral proximal ureteral stones ≤2cm by computed tomography (CT)/Kidney and upper bladder (KUB) radiography who required surgery;
- patients who volunteered to participate in this study.
Who cannot join
- Unable to give informed consent;
- Untreated urinary tract infection;
- Pregnant women;
- Known anatomical abnormalities (such as urinary diversion or ureteral stenosis);
- Urothelial tumors, transplanted kidney stones, irreversible coagulopathy;
- The semi-rigid ureteroscope cannot reach the stone site, ureteroscopy-negative stones, and stones can be removed directly without laser lithotripsy;
- The researchers believe that they are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongnan Hospital, Wuhan University,
Wuhan, Hubei, 430071
Xinghuan Wang, +86 18770426026, wangxinghuan@whu.edu.cn
About this study
The efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared.
Read the detailed description
The target population of this study is patients with proximal ureteral stones who are scheduled to undergo semirigid ureteroscopic laser lithotripsy. After enrollment, the subjects will be randomly assigned to the semirigid ureteroscopic holmium laser (Ho: YAG) lithotripsy group and the semirigid ureteroscopic thulium fiber laser (TFL) lithotripsy group for surgical treatment. The subjects will be followed up after surgery, and the collected data will be summarized and analyzed after the study.
- Conditions
- Urolithiasis, Proximal Ureteral Stone
- Being tested
- Thulium Fiber laser (TFL) lithotripsy, Ho: YAG lithotripsy
- Keywords
- Proximal ureteral stones, Ho: YAG lithotripsy, Thulium Fiber laser (TFL) lithotripsy, Semirigid ureteroscopic lithotripsy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium Fiber laser (TFL) lithotripsyDevice
Patients with proximal ureteral stones undergoing ureteroscopic lithotripsy using thulium laser lithotripsy.
Ho: YAG lithotripsyDevice
Ho:YAG laser lithotripsy was used in patients with proximal ureteral stones undergoing ureteroscopic lithotripsy.
| Study group | Role | What they receive |
|---|---|---|
| Ho: YAG lithotripsy | Active comparator | Ho; YAG laser therapy device is used. The patient adopts lithotomy position. After general anesthesia, a semi-rigid ureteroscope is used to enter the bladder through the urethra to observe the ureteral opening, and then a hydrophilic guide wire is inserted into the ureter on the affected side. After the semi-rigid ureteroscope slowly enters along the hydrophilic guide wire and reaches the bottom of the stone, the laser optical fiber of the laser therapy device is inserted into the working channel of the ureteroscope so that the end of the optical fiber is exposed in the field of view of the ureteroscope. After the laser therapy device sets the lithotripsy parameters, the optical fiber is aimed at the stone for laser lithotripsy. Receives: Device: Ho: YAG lithotripsy |
| Thulium Fiber laser (TFL) lithotripsy | Experimental | The patient adopts lithotomy position. After general anesthesia, a semi-rigid ureteroscope is used to enter the bladder through the urethra to observe the ureteral opening, and then a hydrophilic guide wire is inserted into the ureter on the affected side. After the semi-rigid ureteroscope slowly enters along the hydrophilic guide wire and reaches the bottom of the stone, the laser fiber of the laser therapy machine is inserted into the working channel of the ureteroscope so that the end of the fiber is exposed to the field of view of the ureteroscope. Using the TFL laser therapy device, after setting the lithotripsy parameters, the fiber is aimed at the stone for laser lithotripsy. Receives: Device: Thulium Fiber laser (TFL) lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate (SFR)
Stone-free rate (SFR) after single-session laser lithotripsy using a semirigid ureteroscope without an auxiliary procedure assessed by CT/X-ray at 2-4 weeks follow-up after laser lithotripsy.
Measured: 2-4 weeks after surgery
Secondary outcomes (4)
Operative time
the time of laser lithotripsy
Measured: Immediately during surgery
Intraoperative complications
bleeding, ureteral perforation, ureteral wall injury, or intraoperative adverse events leading to termination of surgery
Measured: Immediately during surgery
Postoperative complications
Occurrence of postoperative complications
Measured: 2-4 weeks after surgery
Additional procedures
If semi-rigid ureteroscopy combined with laser lithotripsy fails, it is converted to flexible ureteroscopy, PCNL, laparoscopic lithotomy. In addition, ESWL treatment is performed before the double-J stent is removed after surgery.lithotripsy, and postoperative ESWL treatment before removal of the ureteral stents, among others.
Measured: Intraoperatively and before removal of the Ureteral stents
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start26 Jun 2024 (estimated)
- Primary completion26 Jan 2025 (estimated)
- Study completion26 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489366
- Sponsor's protocol ID
- 20240173
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06489366
- Acronym / sponsor ID
- 20240173
- Conditions
- Urolithiasis, Proximal Ureteral Stone
- Keywords
- Proximal ureteral stones, Ho: YAG lithotripsy, Thulium Fiber laser (TFL) lithotripsy, Semirigid ureteroscopic lithotripsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 26 Jun 2024 (estimated)
- Primary completion
- 26 Jan 2025 (estimated)
- Study completion
- 26 Feb 2025 (estimated)
- First posted
- 5 Jul 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 efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared.
Detailed description
The target population of this study is patients with proximal ureteral stones who are scheduled to undergo semirigid ureteroscopic laser lithotripsy. After enrollment, the subjects will be randomly assigned to the semirigid ureteroscopic holmium laser (Ho: YAG) lithotripsy group and the semirigid ureteroscopic thulium fiber laser (TFL) lithotripsy group for surgical treatment. The subjects will be followed up after surgery, and the collected data will be summarized and analyzed after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ho: YAG lithotripsy | Active comparator | Device: Ho: YAG lithotripsyHo; YAG laser therapy device is used. The patient adopts lithotomy position. After general anesthesia, a semi-rigid ureteroscope is used to enter the bladder through the urethra to observe the ureteral opening, and then a hydrophilic guide wire is inserted into the ureter on the affected side. After the semi-rigid ureteroscope slowly enters along the hydrophilic guide wire and reaches the bottom of the stone, the laser optical fiber of the laser therapy device is inserted into the working channel of the ureteroscope so that the end of the optical fiber is exposed in the field of view of the ureteroscope. After the laser therapy device sets the lithotripsy parameters, the optical fiber is aimed at the stone for laser lithotripsy. |
| Thulium Fiber laser (TFL) lithotripsy | Experimental | Device: Thulium Fiber laser (TFL) lithotripsyThe patient adopts lithotomy position. After general anesthesia, a semi-rigid ureteroscope is used to enter the bladder through the urethra to observe the ureteral opening, and then a hydrophilic guide wire is inserted into the ureter on the affected side. After the semi-rigid ureteroscope slowly enters along the hydrophilic guide wire and reaches the bottom of the stone, the laser fiber of the laser therapy machine is inserted into the working channel of the ureteroscope so that the end of the fiber is exposed to the field of view of the ureteroscope. Using the TFL laser therapy device, after setting the lithotripsy parameters, the fiber is aimed at the stone for laser lithotripsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old;
- patients diagnosed with unilateral proximal ureteral stones ≤2cm by computed tomography (CT)/Kidney and upper bladder (KUB) radiography who required surgery;
- patients who volunteered to participate in this study.
Key exclusion criteria (7 listed)
- Unable to give informed consent;
- Untreated urinary tract infection;
- Pregnant women;
- Known anatomical abnormalities (such as urinary diversion or ureteral stenosis);
- Urothelial tumors, transplanted kidney stones, irreversible coagulopathy;
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 |
|---|---|---|
| Thulium Fiber laser (TFL) lithotripsyPatients with proximal ureteral stones undergoing ureteroscopic lithotripsy using thulium laser lithotripsy. | Device | Thulium Fiber laser (TFL) lithotripsy |
| Ho: YAG lithotripsyHo:YAG laser lithotripsy was used in patients with proximal ureteral stones undergoing ureteroscopic lithotripsy. | Device | Ho: YAG lithotripsy |
Primary outcome
Stone-free rate (SFR)
Time frame: 2-4 weeks after surgery
Stone-free rate (SFR) after single-session laser lithotripsy using a semirigid ureteroscope without an auxiliary procedure assessed by CT/X-ray at 2-4 weeks follow-up after laser lithotripsy.
4 secondary outcomes
Operative time
Time frame: Immediately during surgery
Intraoperative complications
Time frame: Immediately during surgery
Postoperative complications
Time frame: 2-4 weeks after surgery
Additional procedures
Time frame: Intraoperatively and before removal of the Ureteral stents
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thulium Fiber laser (TFL) lithotripsy and Ho: YAG lithotripsy in people with Urolithiasis and Proximal Ureteral Stone, run by Zhongnan Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 5 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinghuan Wang (+86 18770426026, wangxinghuan@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (SFR) (time frame: 2-4 weeks after surgery). 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 5 Jul 2024.