Kidney StoneTFLNCT05814133
Thulium Fiber Laser Prospective Trial
A study testing Thulium Fiber Laser in people with Kidney Stone, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Thulium Fiber Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 15 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required
- Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
- Must be 18 years or older
- Must be able to give consent
- Bilateral ureteroscopy will be permitted but only the first side will be included in the study
Who cannot join
- Concomitant stones in the ureter
- Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
- Prior radiotherapy to the abdomen or pelvis
- Neurogenic bladder or spinal cord injury
- Pregnancy
- Untreated Urinary Tract Infection (UTI)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Naeem Bhojani, MD, naeem.bhojani@gmail.com
Kahina Bensaadi, kahina.bensaadi.chum@ssss.gouv.qc.ca
About this study
Official title: Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis
This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.
Read the detailed description
Flexible ureteroscopy is considered the first-line therapy for renal stones < 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.
- Conditions
- Kidney Stone
- Being tested
- Thulium Fiber Laser
- Keywords
- ureteroscopy, lithotripsy, thulium fiber laser
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium Fiber LaserDevice
Thulium Fiber Laser will be used to break renal stones < 2 cm into fragments small enough to remove or pass spontaneously through the ureter.
| Study group | Role | What they receive |
|---|---|---|
| Lithotripsy | Experimental | Ureteroscopy with lithotripsy using the Thulium Fiber Laser Receives: Device: Thulium Fiber Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean total operative time
Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.
Measured: during the procedure
Secondary outcomes (1)
Rate of stone retropulsion
Review of the procedure video recording to assess stone retropulsion occurence during stone lithotripsy
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start15 Jan 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Columbia University, University of California, San Diego, Mayo Clinic, Ohio State University, Vanderbilt University, The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Naeem Bhojani, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814133
- Sponsor's protocol ID
- 2023-11370
- Other IDs
- 2023
- Acronym
- TFL
- Status last verified
- Jan 2024
- First submitted
- 9 Mar 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kronenberg P, Traxer O. Update on lasers in urology 2014: current assessment on holmium:yttrium-aluminum-garnet (Ho:YAG) laser lithotripter settings and laser fibers. World J Urol. 2015 Apr;33(4):463-9. doi: 10.1007/s00345-014-1395-1. Epub 2014 Sep 4.
PubMed 25185524Nazif OA, Teichman JM, Glickman RD, Welch AJ. Review of laser fibers: a practical guide for urologists. J Endourol. 2004 Nov;18(9):818-29. doi: 10.1089/end.2004.18.818.
PubMed 15659912Khusid JA, Khargi R, Seiden B, Sadiq AS, Atallah WM, Gupta M. Thulium fiber laser utilization in urological surgery: A narrative review. Investig Clin Urol. 2021 Mar;62(2):136-147. doi: 10.4111/icu.20200467.
PubMed 33660440Kronenberg P, Hameed BZ, Somani B. Outcomes of thulium fibre laser for treatment of urinary tract stones: results of a systematic review. Curr Opin Urol. 2021 Mar 1;31(2):80-86. doi: 10.1097/MOU.0000000000000853.
PubMed 33470684Traxer O, Corrales M. Managing Urolithiasis with Thulium Fiber Laser: Updated Real-Life Results-A Systematic Review. J Clin Med. 2021 Jul 30;10(15):3390. doi: 10.3390/jcm10153390.
PubMed 34362169Law KE, Lowndes BR, Kelley SR, Blocker RC, Larson DW, Hallbeck MS, Nelson H. NASA-Task Load Index Differentiates Surgical Approach: Opportunities for Improvement in Colon and Rectal Surgery. Ann Surg. 2020 May;271(5):906-912. doi: 10.1097/SLA.0000000000003173.
PubMed 30614878
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis
- ClinicalTrials.gov ID
- NCT05814133
- Acronym / sponsor ID
- TFL / 2023-11370
- Conditions
- Kidney Stone
- Keywords
- ureteroscopy, lithotripsy, thulium fiber laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- University of British Columbia, Columbia University, University of California, San Diego, Mayo Clinic, Ohio State University, Vanderbilt University, The Cleveland Clinic
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 14 Apr 2023 (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.
This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.
Detailed description
Flexible ureteroscopy is considered the first-line therapy for renal stones < 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithotripsy | Experimental | Device: Thulium Fiber LaserUreteroscopy with lithotripsy using the Thulium Fiber Laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required
- Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
- Must be 18 years or older
- Must be able to give consent
- Bilateral ureteroscopy will be permitted but only the first side will be included in the study
Key exclusion criteria (6 listed)
- Concomitant stones in the ureter
- Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
- Prior radiotherapy to the abdomen or pelvis
- Neurogenic bladder or spinal cord injury
- Pregnancy
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 LaserThulium Fiber Laser will be used to break renal stones < 2 cm into fragments small enough to remove or pass spontaneously through the ureter. | Device | Lithotripsy |
Primary outcome
Mean total operative time
Time frame: during the procedure
Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.
1 secondary outcome
Rate of stone retropulsion
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 25185524Kronenberg P, Traxer O. Update on lasers in urology 2014: current assessment on holmium:yttrium-aluminum-garnet (Ho:YAG) laser lithotripter settings and laser fibers. World J Urol. 2015 Apr;33(4):463-9. doi: 10.1007/s00345-014-1395-1. Epub 2014 Sep 4.
- Background: PubMed 15659912Nazif OA, Teichman JM, Glickman RD, Welch AJ. Review of laser fibers: a practical guide for urologists. J Endourol. 2004 Nov;18(9):818-29. doi: 10.1089/end.2004.18.818.
- Background: PubMed 33660440Khusid JA, Khargi R, Seiden B, Sadiq AS, Atallah WM, Gupta M. Thulium fiber laser utilization in urological surgery: A narrative review. Investig Clin Urol. 2021 Mar;62(2):136-147. doi: 10.4111/icu.20200467.
- Background: PubMed 33470684Kronenberg P, Hameed BZ, Somani B. Outcomes of thulium fibre laser for treatment of urinary tract stones: results of a systematic review. Curr Opin Urol. 2021 Mar 1;31(2):80-86. doi: 10.1097/MOU.0000000000000853.
- Background: PubMed 34362169Traxer O, Corrales M. Managing Urolithiasis with Thulium Fiber Laser: Updated Real-Life Results-A Systematic Review. J Clin Med. 2021 Jul 30;10(15):3390. doi: 10.3390/jcm10153390.
- Background: PubMed 30614878Law KE, Lowndes BR, Kelley SR, Blocker RC, Larson DW, Hallbeck MS, Nelson H. NASA-Task Load Index Differentiates Surgical Approach: Opportunities for Improvement in Colon and Rectal Surgery. Ann Surg. 2020 May;271(5):906-912. doi: 10.1097/SLA.0000000000003173.
- Chew \* Ben H., Knudsen BE, Molina WR. Mp79-19 comparison of dusting and fragmenting using the new super pulse thulium fiber laser to a 120w holmium:yag laser. Journal of Urology. 2019 Apr;201(Supplement 4):e1159-60.Link provided by the sponsor.
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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.
Naeem Bhojani, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
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 in people with Kidney Stone, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 5 inclusion and 6 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 31 Jan 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 Canada. 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 Naeem Bhojani, M.D (5148908000 ext. 22931, naeem.bhojani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean total operative time (time frame: during the procedure). 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 NCT05814133, which also lists 6 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 31 Jan 2024.