NephrolithiasisNCT05350423
Trial Assessing Renal Damage During Ureteroscopy
A study testing Thulium Fibre Laser and Holmium:Yttrium-Aluminum-Garnet in people with Nephrolithiasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is an ongoing randomized controlled trial of patients undergoing URSLL with unilateral non-obstructing renal stones. Patients are randomized to undergo URSLL with either the TFL or Ho:YAG laser. Each patient's urine is collected immediately pre-op (V1), 1 hour post-op (V2), and 10 days post-op (POD#10, V3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Thulium Fibre Laser and Holmium:Yttrium-Aluminum-Garnet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 28 Nov 2022
- 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
- Age greater than or equal to 18 years
- Patients undergoing unilateral ureteroscopic laser lithotripsy for the treatment of non-obstructing renal stones
- Total stone burden between 5 and 20 mm
Who cannot join
- Presence of pre-existing indwelling ureteral stent
- Presence of hydronephrosis preoperatively (on either side)
- CKD as defined by eGFR < 60 mL/min
- GU anatomical anomalies (including urinary diversion, solitary kidney, ureteral stricture disease, ureteropelvic junction obstruction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Urinary Biomarkers to Quantify Degree of Renal, Parenchymal and Urothelial Damage During Ureteroscopy
This is an ongoing randomized controlled trial of patients undergoing URSLL with unilateral non-obstructing renal stones. Patients are randomized to undergo URSLL with either the TFL or Ho:YAG laser. Each patient's urine is collected immediately pre-op (V1), 1 hour post-op (V2), and 10 days post-op (POD#10, V3). Samples are analyzed by enzyme-linked immunosorbent assay (ELISA) for the following biomarkers: Kidney injury molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), and β2-microglobulin (β2M), then normalized to urine creatinine.
Read the detailed description
Patients scheduled for ureteroscopic laser lithotripsy (URSLL) will be screened and if eligible and agreeable, enrolled into the study. Patients will then be randomized preoperatively via block randomization in groups of 5 to receive lithotripsy with either Ho:YAG or TFL laser intraoperatively. All patients enrolled will have a ureteral stent placed at the end of the procedure.
After induction of anesthesia but before any surgical intervention, the surgeon will empty the bladder and collect a sample of urine that will serve as the "Preoperative Urine Sample". One hour following the end of the procedure, a second sample of urine will be collected from the Foley catheter that will serve as the "Immediate Post-Op Urine Sample". A third and final urine sample of urine will be collected approximately 10 days postoperatively just prior to stent removal and serve as the "Follow-up urine sample". Patients for whom all three urine specimens are collected will be considered to have completed the study. Immediately after collection, the samples will be stored in a freezer at -80 ºC. All samples will be analyzed for biomarkers of renal parenchymal injury to determine differences between pre- and postoperative concentrations. The biomarkers that will be quantified include Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), and Beta-2-microglobulin (B2M).
Concentrations of urinary biomarkers are determined in duplicate from urine samples using the multiplex cytokine panel [MILLIPLEX MAP Human Kidney Injury Panel 1 (KIM-1), Panel 2 (N-GAL2) and Panel 3 (B2 microglobulin)- Millipore Corp., Burlington, MA] as per manufacturer's instructions. The urine samples were 1:2 diluted for Panel 1, 1:100 diluted for Panel 2 and 1:500 diluted for Panel 3. The kit provided lyophilized pre-mixed standard was reconstituted and used to generate 6-point serial dilutions and run on assay plate along with the samples. Analyte median fluorescent intensity (MFI) values were obtained.
Anticipate enrollment is 108 patients total (54 in each cohort) to adequately power the study based upon an alpha of 0.05 statistical power of 0.80.
- Conditions
- Nephrolithiasis
- Being tested
- Thulium Fibre Laser, Holmium:Yttrium-Aluminum-Garnet
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium Fibre LaserDevice
Also called TFL
The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
Holmium:Yttrium-Aluminum-GarnetDevice
Also called Ho:YAG
The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
| Study group | Role | What they receive |
|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) Receives: Device: Thulium Fibre Laser |
| Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) | Experimental | Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser Receives: Device: Holmium:Yttrium-Aluminum-Garnet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kidney Injury Molecule-1 (KIM-1)
Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Measured: Baseline, 1 hour postoperatively, and 10 days postoperatively
Change in Neutrophil Gelatinase-associated Lipocalin (NGAL)
Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Measured: Baseline, 1 hour postoperatively, and 10 days postoperatively
Change in β2-microglobulin (β2M)
Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Measured: Baseline, 1 hour postoperatively, and 10 days postoperatively
Secondary outcomes (1)
Operative Time
Operative time (minutes) is calculated from time of procedure start (insertion of endoscope into urethral meatus) to time of removal of endoscope from urethral meatus after procedure completion.
Measured: Day 1, Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start22 Oct 2021
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
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 NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mantu Gupta, Icahn School of Medicine at Mount Sinai
- Investigators
- Mantu Gupta, Principal investigator, Department of Urology, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350423
- Sponsor's protocol ID
- STUDY-21-00084
- Other IDs
- GCO# 21-0054
- Status last verified
- Nov 2023
- First submitted
- 22 Apr 2022
- Last updated
- 7 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data will be presented/shared as aggregates.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Urinary Biomarkers to Quantify Degree of Renal, Parenchymal and Urothelial Damage During Ureteroscopy
- ClinicalTrials.gov ID
- NCT05350423
- Acronym / sponsor ID
- STUDY-21-00084
- Conditions
- Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 7 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an ongoing randomized controlled trial of patients undergoing URSLL with unilateral non-obstructing renal stones. Patients are randomized to undergo URSLL with either the TFL or Ho:YAG laser. Each patient's urine is collected immediately pre-op (V1), 1 hour post-op (V2), and 10 days post-op (POD#10, V3). Samples are analyzed by enzyme-linked immunosorbent assay (ELISA) for the following biomarkers: Kidney injury molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), and β2-microglobulin (β2M), then normalized to urine creatinine.
Detailed description
Patients scheduled for ureteroscopic laser lithotripsy (URSLL) will be screened and if eligible and agreeable, enrolled into the study. Patients will then be randomized preoperatively via block randomization in groups of 5 to receive lithotripsy with either Ho:YAG or TFL laser intraoperatively. All patients enrolled will have a ureteral stent placed at the end of the procedure.
After induction of anesthesia but before any surgical intervention, the surgeon will empty the bladder and collect a sample of urine that will serve as the "Preoperative Urine Sample". One hour following the end of the procedure, a second sample of urine will be collected from the Foley catheter that will serve as the "Immediate Post-Op Urine Sample". A third and final urine sample of urine will be collected approximately 10 days postoperatively just prior to stent removal and serve as the "Follow-up urine sample". Patients for whom all three urine specimens are collected will be considered to have completed the study. Immediately after collection, the samples will be stored in a freezer at -80 ºC. All samples will be analyzed for biomarkers of renal parenchymal injury to determine differences between pre- and postoperative concentrations. The biomarkers that will be quantified include Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), and Beta-2-microglobulin (B2M).
Concentrations of urinary biomarkers are determined in duplicate from urine samples using the multiplex cytokine panel [MILLIPLEX MAP Human Kidney Injury Panel 1 (KIM-1), Panel 2 (N-GAL2) and Panel 3 (B2 microglobulin)- Millipore Corp., Burlington, MA] as per manufacturer's instructions. The urine samples were 1:2 diluted for Panel 1, 1:100 diluted for Panel 2 and 1:500 diluted for Panel 3. The kit provided lyophilized pre-mixed standard was reconstituted and used to generate 6-point serial dilutions and run on assay plate along with the samples. Analyte median fluorescent intensity (MFI) values were obtained.
Anticipate enrollment is 108 patients total (54 in each cohort) to adequately power the study based upon an alpha of 0.05 statistical power of 0.80.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Device: Thulium Fibre LaserPatients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) |
| Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) | Experimental | Device: Holmium:Yttrium-Aluminum-GarnetPatients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years
- Patients undergoing unilateral ureteroscopic laser lithotripsy for the treatment of non-obstructing renal stones
- Total stone burden between 5 and 20 mm
Key exclusion criteria (4 listed)
- Presence of pre-existing indwelling ureteral stent
- Presence of hydronephrosis preoperatively (on either side)
- CKD as defined by eGFR < 60 mL/min
- GU anatomical anomalies (including urinary diversion, solitary kidney, ureteral stricture disease, ureteropelvic junction obstruction)
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 Fibre LaserAlso: TFLThe TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation. | Device | Thulium Fibre Laser (TFL) |
| Holmium:Yttrium-Aluminum-GarnetAlso: Ho:YAGThe Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy. | Device | Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) |
Primary outcome
Change in Kidney Injury Molecule-1 (KIM-1)
Time frame: Baseline, 1 hour postoperatively, and 10 days postoperatively
Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Change in Neutrophil Gelatinase-associated Lipocalin (NGAL)
Time frame: Baseline, 1 hour postoperatively, and 10 days postoperatively
Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
Change in β2-microglobulin (β2M)
Time frame: Baseline, 1 hour postoperatively, and 10 days postoperatively
Urinary biomarker - a specific biomarker of renal damage to measure the degree of renal parenchymal damage.
1 secondary outcome
Operative Time
Time frame: Day 1, Intraoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. All data will be presented/shared as aggregates.
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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.
Mantu Gupta principal investigator
Department of Urology, Icahn School of Medicine at Mount Sinai
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 Fibre Laser and Holmium:Yttrium-Aluminum-Garnet in people with Nephrolithiasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 4 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 7 Dec 2023. 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 United States. 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 7 Dec 2023). 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?
Change in Kidney Injury Molecule-1 (KIM-1) (time frame: Baseline, 1 hour postoperatively, and 10 days postoperatively). The study lists 3 primary outcomes in all. 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 7 Dec 2023.