Kidney StonesNCT01226875
Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi
A study testing SWL: Shock Wave Lithotripsy Intervention in people with Kidney Stones, run by Unity Health Toronto at 3 sites in Canada.
Trial summary
Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL energy is focused on in order to break kidney stones and this energy can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- SWL: Shock Wave Lithotripsy Intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2011to Apr 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stone must be radiopaque on a KUB (kidney, ureter and bladder) radiograph, and located within the renal collecting system.
- Patients must have had a CT scan within the past 30 days.
- Stones must be solitary, between 5 and 15 mm in maximal diameter.
- Patient must consent to the trial and be willing to return to their respective lithotripsy unit at 2 weeks and 3 months for follow-up.
- Patients must be treated on the Storz Modulith SLX-F2 machine
Who cannot join
- More than one renal calculus on the treated side.
- Radiolucent stones (uric acid, indinavir) or cystine stones.
- Stone size < 5 mm and > 15 mm.
- Previous surgical intervention on upper tracts within past five years.
- Congenital anatomic anomalies of the kidney, ureters or bladder (such as calyceal diverticulum, horseshoe kidney, etc.)
- Patient currently taking an α-blocker (alfuzosin, terazosin, doxazosin, tamsulosin, prazosin), calcium channel blocker (verapamil, diltiazem, nifedipine, nicardipine, bepridil, mibefradil), or corticosteroids.
Show all 12Show fewer
- Pregnancy.
- Age < 18 years.
- Active urinary tract infection.
- Patient exceed weight limit for SWL table (>500 lbs)
- Previous SWL treatment for this stone.
- Uncorrected coagulopathy
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St. Joseph's Hospital, University of Western Ontario
London, Ontario
St. Michael's Hospital, University of Toronto, Toronto, Lithotripsy suite, 5th floor Cardinal Carter North Wing
Toronto, Ontario, M5B 1W8
Vancouver General Hospital, Jim Pattison Pavilion G floor station 5 GI/GU Lithotripsy suite
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Multicentred, Randomized Control Trial Comparing Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi
Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL energy is focused on in order to break kidney stones and this energy can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. This is a multi-centered, randomized study comparing the single treatment success rates of narrow and wide focal zones during SWL.
Read the detailed description
Shock wave lithotripsy (SWL) is a safe and non-invasive treatment for kidney stones. The SWL machine that is currently in use has a unique feature: the focal zone or the energy that the SWL energy is focused on in order to break kidney stones can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. Previous lithotripters have only offered one focal size that corresponded to a narrow range. The objective of this study is to compare the single-treatment success rates of narrow and wide focal zones for the shock wave lithotripsy of renal stones between 5 and 15 mm in greatest diameter, while maintaining a constant overall lithotripsy energy level. A wide focal zone may offer some trade-offs when compared with the traditional narrow focal zone: since the area being treated is larger, it is more likely that the stone will receive adequate energy as it moves with patient breathing during treatment, and less energy per cubic inch will be delivered to the kidney around the stone (which might lead to a lower degree of renal injury); on the other hand less energy per cubic inch will also be delivered to the stone, so that stone fragmentation might be inferior to that with a narrow focal zone. Thus, with this study we want to determine whether there is a significant difference in both stone fragmentation and in renal injury (as measured by the incidence of post-treatment renal hematoma or bruises, and by measuring urinary markers indicating the degree of renal cellular damage). Aside from the random choice of focal zone size, there will be no change to the standard of care for lithotripsy treatment. We predict that the narrow focal shock zone will result in superior stone fragmentation, with higher single-treatment stone free and success rates. However, we may identify a slight increased incidence in the rate of subcapsular renal hematoma and renal damage, as detected by urinary markers.
- Conditions
- Kidney Stones
- Being tested
- SWL: Shock Wave Lithotripsy Intervention
- Keywords
- SWL, kidney stones, renal calculi
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWL: Shock Wave Lithotripsy InterventionProcedure or surgery
Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.
| Study group | Role | What they receive |
|---|---|---|
| A (Narrow focus, LP) | Active comparator | A (Narrow focus): stone is in lower pole of kidney and SWL using narrow focus on lithotripter Receives: Procedure: SWL: Shock Wave Lithotripsy Intervention |
| B (Wide focus, LP) | Active comparator | B: stone is in lower pole of kidney and SWL using wide focus on lithotripter Receives: Procedure: SWL: Shock Wave Lithotripsy Intervention |
| C (Narrow focus, no LP) | Active comparator | C: stone is in no-lower pole of kidney and SWL using narrow focus on lithotripter Receives: Procedure: SWL: Shock Wave Lithotripsy Intervention |
| D (Wide focus, no LP) | Active comparator | D: stone is in no-lower pole of kidney and SWL using wide focus on lithotripter Receives: Procedure: SWL: Shock Wave Lithotripsy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SWL efficiency quotient comparison between narrow focus vs wide focus
Comparison of single-treatment lithotripsy success rates at 2 and 12 weeks post-lithotripsy. Successful treatment will be defined as either stone-free status or presence of clinically insignificant asymptomatic residual fragments ≤ 4 mm. SWL efficiency quotient for the treatment groups, as calculated by the standardized formula: % stone-free divided by (100 + % re-treated + % auxiliary procedures).
Measured: 2 and 12 weeks
Secondary outcomes (5)
Incidence of perirenal hematomas
Comparing the narrow and wide foci for the presence of perirenal hematomas post treatment on ultrasound.
Measured: post treatment
Biomarkers for renal injury
Comparisons of urinary markers for identifying renal injury
Measured: day 0; day 1; 1 week
Time to stone passage
Time it took to pass the stone for both arms will be compared for the 3 month follow up time.
Measured: 12 weeks
Pain will be compared between narrow vs wide focus arms
Visual analog pain scores will be compared between arms.
Measured: day 0 (post treatment)
Complication rates
Complication rates will be compared between narrow and wide focus treatment arms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University of Western Ontario, Canada, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- John Honey, MD, Principal investigator, St. Michael's Hospital, University of TorontoKen Pace, MD, Principal investigator, St. Michael's Hospital, University of TorontoBen Chew, MD, Principal investigator, University of British Columbia - Vancouver Coastal Health Research InstituteRyan Paterson, MD, Principal investigator, University of British Columbia - Vancouver Coastal Health Research InstituteHassan Razvi, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226875
- Sponsor's protocol ID
- 10-225
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2010
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentred, Randomized Control Trial Comparing Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi
- ClinicalTrials.gov ID
- NCT01226875
- Acronym / sponsor ID
- 10-225
- Conditions
- Kidney Stones
- Keywords
- SWL, kidney stones, renal calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto, University of Western Ontario, Canada, University of British Columbia
- Study start
- Jan 2011 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Oct 2010 (estimated)
- 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.
Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL energy is focused on in order to break kidney stones and this energy can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. This is a multi-centered, randomized study comparing the single treatment success rates of narrow and wide focal zones during SWL.
Detailed description
Shock wave lithotripsy (SWL) is a safe and non-invasive treatment for kidney stones. The SWL machine that is currently in use has a unique feature: the focal zone or the energy that the SWL energy is focused on in order to break kidney stones can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. Previous lithotripters have only offered one focal size that corresponded to a narrow range. The objective of this study is to compare the single-treatment success rates of narrow and wide focal zones for the shock wave lithotripsy of renal stones between 5 and 15 mm in greatest diameter, while maintaining a constant overall lithotripsy energy level. A wide focal zone may offer some trade-offs when compared with the traditional narrow focal zone: since the area being treated is larger, it is more likely that the stone will receive adequate energy as it moves with patient breathing during treatment, and less energy per cubic inch will be delivered to the kidney around the stone (which might lead to a lower degree of renal injury); on the other hand less energy per cubic inch will also be delivered to the stone, so that stone fragmentation might be inferior to that with a narrow focal zone. Thus, with this study we want to determine whether there is a significant difference in both stone fragmentation and in renal injury (as measured by the incidence of post-treatment renal hematoma or bruises, and by measuring urinary markers indicating the degree of renal cellular damage). Aside from the random choice of focal zone size, there will be no change to the standard of care for lithotripsy treatment. We predict that the narrow focal shock zone will result in superior stone fragmentation, with higher single-treatment stone free and success rates. However, we may identify a slight increased incidence in the rate of subcapsular renal hematoma and renal damage, as detected by urinary markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A (Narrow focus, LP) | Active comparator | Procedure: SWL: Shock Wave Lithotripsy InterventionA (Narrow focus): stone is in lower pole of kidney and SWL using narrow focus on lithotripter |
| B (Wide focus, LP) | Active comparator | Procedure: SWL: Shock Wave Lithotripsy InterventionB: stone is in lower pole of kidney and SWL using wide focus on lithotripter |
| C (Narrow focus, no LP) | Active comparator | Procedure: SWL: Shock Wave Lithotripsy InterventionC: stone is in no-lower pole of kidney and SWL using narrow focus on lithotripter |
| D (Wide focus, no LP) | Active comparator | Procedure: SWL: Shock Wave Lithotripsy InterventionD: stone is in no-lower pole of kidney and SWL using wide focus on lithotripter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stone must be radiopaque on a KUB (kidney, ureter and bladder) radiograph, and located within the renal collecting system.
- Patients must have had a CT scan within the past 30 days.
- Stones must be solitary, between 5 and 15 mm in maximal diameter.
- Patient must consent to the trial and be willing to return to their respective lithotripsy unit at 2 weeks and 3 months for follow-up.
- Patients must be treated on the Storz Modulith SLX-F2 machine
Key exclusion criteria (12 listed)
- More than one renal calculus on the treated side.
- Radiolucent stones (uric acid, indinavir) or cystine stones.
- Stone size < 5 mm and > 15 mm.
- Previous surgical intervention on upper tracts within past five years.
- Congenital anatomic anomalies of the kidney, ureters or bladder (such as calyceal diverticulum, horseshoe kidney, etc.)
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 |
|---|---|---|
| SWL: Shock Wave Lithotripsy InterventionShock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting. | Procedure or surgery | A (Narrow focus, LP), B (Wide focus, LP), C (Narrow focus, no LP), D (Wide focus, no LP) |
Primary outcome
SWL efficiency quotient comparison between narrow focus vs wide focus
Time frame: 2 and 12 weeks
Comparison of single-treatment lithotripsy success rates at 2 and 12 weeks post-lithotripsy. Successful treatment will be defined as either stone-free status or presence of clinically insignificant asymptomatic residual fragments ≤ 4 mm. SWL efficiency quotient for the treatment groups, as calculated by the standardized formula: % stone-free divided by (100 + % re-treated + % auxiliary procedures).
5 secondary outcomes
Incidence of perirenal hematomas
Time frame: post treatment
Biomarkers for renal injury
Time frame: day 0; day 1; 1 week
Time to stone passage
Time frame: 12 weeks
Pain will be compared between narrow vs wide focus arms
Time frame: day 0 (post treatment)
Complication rates
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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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.
John Honey, MD principal investigator
St. Michael's Hospital, University of Toronto
Ken Pace, MD principal investigator
St. Michael's Hospital, University of Toronto
Ben Chew, MD principal investigator
University of British Columbia - Vancouver Coastal Health Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWL: Shock Wave Lithotripsy Intervention in people with Kidney Stones, run by Unity Health Toronto at 3 sites 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 12 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 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SWL efficiency quotient comparison between narrow focus vs wide focus (time frame: 2 and 12 weeks). 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 6 Oct 2017.