Renal StoneLiThuHolNCT04871984
Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis
An observational study of Renal Stone and Ureteral Stone, run by University Hospital, Angers.
Trial summary
Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone, Ureteral Stone
- What is being tested?
- Ureteroscopy for upper tract stone treatment with Holmium laser and Ureteroscopy for upper tract stone treatment with Thulium laser
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Oct 2022
- How long will I take part?
- 14 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled for ureteroscopy on renal or ureteral stones, which have been previously confirmed by tomography
Who may be able to join
- renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography
- treatment with rigid or flexible ureteroscopy
- laser lithotripsy during the procedure
- bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics)
Who cannot join
- non-use of laser for stone lithotripsy
- pregnant women
- under 18 years old
- refusal to give informed consent
- urinary malformation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ureteroscopy for Upper Tract Lithiasis : Comparison of Costs and Effectiveness of Both Holmium and Thulium Lasers, in a Prospective Monocentric Study.
Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published.
The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers.
The costs and complications will also be studied.
- Conditions
- Renal Stone, Ureteral Stone
- Being tested
- Ureteroscopy for upper tract stone treatment with Holmium laser, Ureteroscopy for upper tract stone treatment with Thulium laser
- Medical subject headings
- Nephrolithiasis, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscopy for upper tract stone treatment with Holmium laserDevice
Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Holmium laser
Ureteroscopy for upper tract stone treatment with Thulium laserDevice
Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Thulium laser
| Study group | Role | What they receive |
|---|---|---|
| Holmium laser lithotripsy | Stone fragmentation are performed with Holmium laser in ureteroscopy Receives: Device: Ureteroscopy for upper tract stone treatment with Holmium laser | |
| Thulium laser lithotripsy | Stone fragmentation are performed with Thulium laser in ureteroscopy Receives: Device: Ureteroscopy for upper tract stone treatment with Thulium laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Urinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free.
Measured: Three months after surgery
Secondary outcomes (3)
Perioperative complications
Recording data about ureteric perforation and bleeding
Measured: During the intervention
Operating time
All surgeries are included
Measured: Immediately after the intervention
Postoperative complications
Recording data according to the Clavien classification (rates of hospitalisation, pain, infection and surgical revision)
Measured: Up to three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 200 participants (estimated)
- Target duration
- 14 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871984
- Sponsor's protocol ID
- ar21-0020v0
- Acronym
- LiThuHol
- Status last verified
- May 2021
- First submitted
- 25 Feb 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Panthier F, Doizi S, Corrales M, Traxer O. Pulsed lasers and endocorporeal laser lithotripsy. Prog Urol. 2021 Jun-Jul;31(8-9):451-457. doi: 10.1016/j.purol.2020.11.008. Epub 2021 Jan 28.
PubMed 33516610Martov AG, Ergakov DV, Guseinov MA, Andronov AS, Dutov SV, Vinnichenko VA, Kovalenko AA. [Initial experience in clinical application of thulium laser contact lithotripsy for transurethral treatment of urolithiasis]. Urologiia. 2018 Mar;(1):112-120. Russian.
PubMed 29634144Rapoport LM, Vinarov AZ, Sorokin NI, Dymov AM, Enikeev DV, Tsarichenko DG, Lekarev VY, Klimov RE, Andreeva VA, Kovalenko AA. [Experimental verification of thulium lithotripsy]. Urologiia. 2018 Dec;(5):74-80. Russian.
PubMed 30575354
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteroscopy for Upper Tract Lithiasis : Comparison of Costs and Effectiveness of Both Holmium and Thulium Lasers, in a Prospective Monocentric Study.
- ClinicalTrials.gov ID
- NCT04871984
- Acronym / sponsor ID
- LiThuHol / ar21-0020v0
- Conditions
- Renal Stone, Ureteral Stone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 4 May 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.
Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published.
The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers.
The costs and complications will also be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holmium laser lithotripsy | – | Device: Ureteroscopy for upper tract stone treatment with Holmium laserStone fragmentation are performed with Holmium laser in ureteroscopy |
| Thulium laser lithotripsy | – | Device: Ureteroscopy for upper tract stone treatment with Thulium laserStone fragmentation are performed with Thulium laser in ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for ureteroscopy on renal or ureteral stones, which have been previously confirmed by tomography
Key inclusion criteria (4 listed)
- renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography
- treatment with rigid or flexible ureteroscopy
- laser lithotripsy during the procedure
- bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics)
Key exclusion criteria (5 listed)
- non-use of laser for stone lithotripsy
- pregnant women
- under 18 years old
- refusal to give informed consent
- urinary malformation
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 |
|---|---|---|
| Ureteroscopy for upper tract stone treatment with Holmium laserRigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Holmium laser | Device | Holmium laser lithotripsy |
| Ureteroscopy for upper tract stone treatment with Thulium laserRigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Thulium laser | Device | Thulium laser lithotripsy |
Primary outcome
Stone free rate
Time frame: Three months after surgery
Urinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free.
3 secondary outcomes
Perioperative complications
Time frame: During the intervention
Operating time
Time frame: Immediately after the intervention
Postoperative complications
Time frame: Up to three months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Background: PubMed 33516610Panthier F, Doizi S, Corrales M, Traxer O. Pulsed lasers and endocorporeal laser lithotripsy. Prog Urol. 2021 Jun-Jul;31(8-9):451-457. doi: 10.1016/j.purol.2020.11.008. Epub 2021 Jan 28.
- Background: PubMed 29634144Martov AG, Ergakov DV, Guseinov MA, Andronov AS, Dutov SV, Vinnichenko VA, Kovalenko AA. [Initial experience in clinical application of thulium laser contact lithotripsy for transurethral treatment of urolithiasis]. Urologiia. 2018 Mar;(1):112-120. Russian.
- Background: PubMed 30575354Rapoport LM, Vinarov AZ, Sorokin NI, Dymov AM, Enikeev DV, Tsarichenko DG, Lekarev VY, Klimov RE, Andreeva VA, Kovalenko AA. [Experimental verification of thulium lithotripsy]. Urologiia. 2018 Dec;(5):74-80. Russian.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Stone and Ureteral Stone, run by University Hospital, Angers.
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 5 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Pierre BIGOT, MD-PhD (0241355830 ext. +33, PiBigot@chu-angers.fr), 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: Three months after surgery). 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 NCT04871984, which also lists 3 linked publications.
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 May 2021.