Stone UreterNCT03526458
Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones
A study testing Holmium:YAG laser in people with Stone Ureter and Stone;Renal, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragmenting urinary stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone Ureter, Stone;Renal, Surgery
- What is being tested?
- Holmium:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 24 Mar 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 at least 18 years of age
- Patients with urinary stones who require endoscopic treatment
Who cannot join
- Patients < 18 years of age
- Pregnant patients
- Pre-menopausal females who have not been on approved birth control for at least 1 month pre-operatively
- Patients with stones known to be refractory to treatment with the holmium laser
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragmenting urinary stones. The clinical practice is to treat urinary stones until the stone is reduced to fragments ≤ 2 mm in size. This is determined by using the laser fiber which is 273 microns to visually estimate the size of the resultant fragments as described by Patel et al, J Endo 2014. Investigators will standardize the effect of stone size by creating a ratio of stone size to treatment time. In this study, the frequency is set at 15Hz. Thus, the study contains two arms: 0.2J\&15Hz, and 0.8J\&15Hz. Patients will be randomized into the two groups by the ratio of 1:1.
Read the detailed description
The only interventions imposed on subjects as a result of this study are (1) pre-procedural randomization to laser lithotripsy with either 0.2J or 0.8J energy setting, and (2) the use of patient information in describing results. All the other activities are part of the routine clinical practice in the department. Participation in the study will not alter the patients' preoperative, or postoperative care. During surgery, patients' stones will be treated in accordance with the routine clinical practice of fragmenting stones into small pieces (<2 mm). All patients enrolled will undergo routine post-operative follow up including clinic appointments and imaging evaluation. Any complications will be recorded, reported, and treated appropriately. A fixed frequency will be used (15Hz). Thus, the study contains two arms: 0.2J\&15Hz, and 0.8J\&15Hz. Patients will be randomized into the two groups by the ratio of 1:1. A total of 1 clinic visit (i.e., the stone surgery, approximately 5-6 hours, depending on the duration of the surgery) is needed for this study.
The study procedures are:
- A study team member who is affiliated with the patient's clinical care (e.g., the surgeon) will initially approach the patients who are scheduled laser lithotripsy treatment of urinary stones. (i.e. informed that there's a research study they may be eligible for, and asked if they want to learn more about it).
- If the patient is interested in the study, a member of the research team will approach him/her for enrollment.
- Once the consent form is obtained, patients' medical background will be reviewed for inclusion/exclusion criteria. Patients who meet the inclusion criteria will be included in the study; patients who do not meet the inclusion criteria will be excluded.
- Patients will be randomized to either 0.2J\&15Hz or 0.8J\&15Hz (randomization ratio 1:1) group.
- Patients will undergo stone surgeries with the laser setting that they are randomized to. The patient's stone(s) will be treated in accordance with the routine clinical practice of fragmenting stone into small pieces (≤ 2mm). The faculty surgeon (i.e., Dr. Nakada) will perform all surgeries.
- Fragmentation time as well as other information (total surgery time, complications, stone information, and number of stones treated) is collected.
- After surgery, the patients will then continue on normal postoperative pathway. Postoperative complications will be collected.
- Conditions
- Stone Ureter, Stone;Renal, Surgery
- Being tested
- Holmium:YAG laser
- Keywords
- Holmium Laser, Laser setting, Stone fragmentation
- Medical subject headings
- Ureterolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium:YAG laserDevice
Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
| Study group | Role | What they receive |
|---|---|---|
| Holmium:YAG laser: 0.2J&15Hz | Active comparator | Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser. Receives: Device: Holmium:YAG laser |
| Holmium:YAG laser: 0.8J&15Hz | Experimental | Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser. Receives: Device: Holmium:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fragmentation Time
The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)
Measured: up to 6 hours
Secondary outcomes (6)
Total Operative Time
Measured: up to 6 hours
Pre-Operative Stone Size
Pre-operative stone size (on pre-operative CT) will be reported in millimeters.
Measured: Retrospective review of health chart at Baseline
Number of Participants With Either Ureteral or Renal Location of Urinary Stone
Urinary stone location will be classified as renal or ureter.
Measured: up to 6 hours
Number of Participants Treated for Either Single or Multiple Urinary Stones
Measured: up to 6 hours
Density of Urinary Stones
Measured: up to 6 hours
Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm
Size of fragments created will be assessed using the laser fiber size as a comparison.
Measured: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start30 Jul 2019
- Primary completion24 Mar 2021
- Study completion24 Mar 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 Stone UreterStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Nakada, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526458
- Sponsor's protocol ID
- 2017-0252
- Other IDs
- A539800, SMPH/UROLOGY, Protocol Version 10/30/2017
- Status last verified
- Aug 2020
- First submitted
- 14 Nov 2017
- Last updated
- 20 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones
- ClinicalTrials.gov ID
- NCT03526458
- Acronym / sponsor ID
- 2017-0252
- Conditions
- Stone Ureter, Stone;Renal, Surgery
- Keywords
- Holmium Laser, Laser setting, Stone fragmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Posted 20 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragmenting urinary stones. The clinical practice is to treat urinary stones until the stone is reduced to fragments ≤ 2 mm in size. This is determined by using the laser fiber which is 273 microns to visually estimate the size of the resultant fragments as described by Patel et al, J Endo 2014. Investigators will standardize the effect of stone size by creating a ratio of stone size to treatment time. In this study, the frequency is set at 15Hz. Thus, the study contains two arms: 0.2J\&15Hz, and 0.8J\&15Hz. Patients will be randomized into the two groups by the ratio of 1:1.
Detailed description
The only interventions imposed on subjects as a result of this study are (1) pre-procedural randomization to laser lithotripsy with either 0.2J or 0.8J energy setting, and (2) the use of patient information in describing results. All the other activities are part of the routine clinical practice in the department. Participation in the study will not alter the patients' preoperative, or postoperative care. During surgery, patients' stones will be treated in accordance with the routine clinical practice of fragmenting stones into small pieces (<2 mm). All patients enrolled will undergo routine post-operative follow up including clinic appointments and imaging evaluation. Any complications will be recorded, reported, and treated appropriately. A fixed frequency will be used (15Hz). Thus, the study contains two arms: 0.2J\&15Hz, and 0.8J\&15Hz. Patients will be randomized into the two groups by the ratio of 1:1. A total of 1 clinic visit (i.e., the stone surgery, approximately 5-6 hours, depending on the duration of the surgery) is needed for this study.
The study procedures are:
- A study team member who is affiliated with the patient's clinical care (e.g., the surgeon) will initially approach the patients who are scheduled laser lithotripsy treatment of urinary stones. (i.e. informed that there's a research study they may be eligible for, and asked if they want to learn more about it).
- If the patient is interested in the study, a member of the research team will approach him/her for enrollment.
- Once the consent form is obtained, patients' medical background will be reviewed for inclusion/exclusion criteria. Patients who meet the inclusion criteria will be included in the study; patients who do not meet the inclusion criteria will be excluded.
- Patients will be randomized to either 0.2J\&15Hz or 0.8J\&15Hz (randomization ratio 1:1) group.
- Patients will undergo stone surgeries with the laser setting that they are randomized to. The patient's stone(s) will be treated in accordance with the routine clinical practice of fragmenting stone into small pieces (≤ 2mm). The faculty surgeon (i.e., Dr. Nakada) will perform all surgeries.
- Fragmentation time as well as other information (total surgery time, complications, stone information, and number of stones treated) is collected.
- After surgery, the patients will then continue on normal postoperative pathway. Postoperative complications will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holmium:YAG laser: 0.2J&15Hz | Active comparator | Device: Holmium:YAG laserPatients are assigned to treat stones with 0.2J\&15Hz of the holmium laser. |
| Holmium:YAG laser: 0.8J&15Hz | Experimental | Device: Holmium:YAG laserPatients are assigned to treat stones with 0.8J\&15Hz of the holmium laser. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients at least 18 years of age
- Patients with urinary stones who require endoscopic treatment
Key exclusion criteria (4 listed)
- Patients < 18 years of age
- Pregnant patients
- Pre-menopausal females who have not been on approved birth control for at least 1 month pre-operatively
- Patients with stones known to be refractory to treatment with the holmium laser
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 laserTreatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones) | Device | Holmium:YAG laser: 0.2J&15Hz, Holmium:YAG laser: 0.8J&15Hz |
Primary outcome
Fragmentation Time
Time frame: up to 6 hours
The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)
6 secondary outcomes
Total Operative Time
Time frame: up to 6 hours
Pre-Operative Stone Size
Time frame: Retrospective review of health chart at Baseline
Number of Participants With Either Ureteral or Renal Location of Urinary Stone
Time frame: up to 6 hours
Number of Participants Treated for Either Single or Multiple Urinary Stones
Time frame: up to 6 hours
Density of Urinary Stones
Time frame: up to 6 hours
Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm
Time frame: up to 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Stephen Nakada, MD principal investigator
University of Wisconsin, Madison
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 in people with Stone Ureter and Stone;Renal, run by University of Wisconsin, Madison 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 2 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 20 Sep 2021. 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 20 Aug 2021). 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?
Fragmentation Time (time frame: up to 6 hours). 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 20 Sep 2021.