UrolithiasisNCT04668586
Laser Lithotripsy During URS - Holmium vs Thulium
A study testing Holmium:YAG laser machine and Thulium Fiber laser machine in people with Urolithiasis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser. The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Holmium:YAG laser machine and Thulium Fiber laser machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 14 Jan 2021to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway
Who cannot join
- Known pathology of the upper urinary tract
- Untreated infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety
The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser.
The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.
The outcomes of the URS procedures are compared for the two treatment arms.
Read the detailed description
The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total.
Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting.
The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.
The outcomes of the URS procedures are compared for the two treatment arms.
- Conditions
- Urolithiasis
- Being tested
- Holmium:YAG laser machine, Thulium Fiber laser machine
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium:YAG laser machineDevice
Ureteroscopy with Holmium:YAG laser lithotripsy
Thulium Fiber laser machineDevice
Ureteroscopy with Thulium Fiber laser lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Holmium:YAG laser machine | Experimental | The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine. Receives: Device: Holmium:YAG laser machine |
| Thulium Fiber laser machine | Experimental | The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine. Receives: Device: Thulium Fiber laser machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Free Rate
Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.
Measured: 3 months after the URS
Secondary outcomes (4)
Operating Time
Surgical operating time
Measured: Decided immediately after the surgery
Intraoperative Complications
Intraoperative complications leading to abruption of the URS procedure
Measured: Decided immediately after the surgery
Postoperative Complications
Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure.
Measured: Within 3 months post endoscopically
Postoperative JJ-stenting
How many needed postendoscopic stunting following the URS procedure
Measured: Decided immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start14 Jan 2021
- Primary completion30 Jun 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- Arm 1: Holmium:YAG laser lithotripsy Arm 2: Thulium Fiber laser lithotripsy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øyvind Ulvik, MD PhD, Principal investigator, Helse-Bergen HF, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668586
- Sponsor's protocol ID
- 170907
- Status last verified
- Mar 2025
- First submitted
- 6 Dec 2020
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPF will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety
- ClinicalTrials.gov ID
- NCT04668586
- Acronym / sponsor ID
- 170907
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Posted 30 Mar 2025
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 the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser.
The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.
The outcomes of the URS procedures are compared for the two treatment arms.
Detailed description
The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total.
Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting.
The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.
The outcomes of the URS procedures are compared for the two treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Arm 1: Holmium:YAG laser lithotripsy Arm 2: Thulium Fiber laser lithotripsy
| Arm | Type | Receives |
|---|---|---|
| Holmium:YAG laser machine | Experimental | Device: Holmium:YAG laser machineThe ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine. |
| Thulium Fiber laser machine | Experimental | Device: Thulium Fiber laser machineThe ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway
Key exclusion criteria (2 listed)
- Known pathology of the upper urinary tract
- Untreated infection
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 |
|---|---|---|
| Holmium:YAG laser machineUreteroscopy with Holmium:YAG laser lithotripsy | Device | Holmium:YAG laser machine |
| Thulium Fiber laser machineUreteroscopy with Thulium Fiber laser lithotripsy | Device | Thulium Fiber laser machine |
Primary outcome
Stone Free Rate
Time frame: 3 months after the URS
Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.
4 secondary outcomes
Operating Time
Time frame: Decided immediately after the surgery
Intraoperative Complications
Time frame: Decided immediately after the surgery
Postoperative Complications
Time frame: Within 3 months post endoscopically
Postoperative JJ-stenting
Time frame: Decided immediately after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPF will not be available to other researchers.
Related trials for Urolithiasis
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
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
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone
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.
Øyvind Ulvik, MD PhD principal investigator
Helse-Bergen HF, Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium:YAG laser machine and Thulium Fiber laser machine in people with Urolithiasis, run by Haukeland University Hospital at 1 site in Norway.
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 1 inclusion and 2 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 30 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 1 site in Norway. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 3 months after the URS). 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 30 Mar 2025.