Percutaneous NephrolithotripsyPhase 3NCT00677196
The StoneBreakerTM Trial
A Phase 3 study testing The stonebreaker arm (LMA Stonebreaker) and Pneumatic Lithotripsy (Swiss LithoClastR) in people with Percutaneous Nephrolithotripsy, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Nephrolithotripsy
- What is being tested?
- The stonebreaker arm (LMA Stonebreaker) and Pneumatic Lithotripsy (Swiss LithoClastR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Sep 2010
- Phase
- Phase 3
- 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
- Patients over the age of 18 undergoing PNL
- Previously untreated renal stones
- Patients with 3 or less individual renal calculi, accessible with a rigid nephroscope
- Stones must be at least >225mm2 area on KUB
- Patient must have a CT scan prior to treatment
Who cannot join
- Patients with an active contraindication for PNL (pregnancy, uncorrected coagulopathy, active urinary infection, contrast allergy)
- Partial staghorn calculi
- Complete staghorn calculi
- Stones in calyceal diverticulum
- Cases requiring multiple tracts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Canadian StoneBreakerTM Trial: A Randomized, Multicentre Trial Comparing The LMA StoneBreakerTM and the Swiss LithoClastR During Percutaneous Nephrolithotripsy.
The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).
Read the detailed description
Objective:
The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).
Rationale:
Percutaneous nephrolithotripsy (PNL) is the preferred treatment modality for renal stones greater than 2cm in diameter.
The pneumatic lithotriptor functions as a pneumatic jackhammer, providing either a single pulse or a train of pulses at 2Hz as determined by the operator. Its chief advantage is its ability to fragment even the hardest calculi. The pneumatic lithotriptor, while extremely effective, does not utilize thermal energy and therefore has no risk of thermal damage to the surrounding tissue. The pneumatic lithotriptor currently in use, the Swiss LithoClast is powered by compressed medical air. The primary disadvantage of this device is that the residual calculi must be individually removed with forceps following fragmentation.
The StoneBreaker, manufactured by the Laryngeal Mask Airway Company, is a novel hand-held pneumatic lithotriptor. This device is powered by a compressed carbon dioxide cartridge.
Hypothesis:
The LMA StoneBreaker, provides more efficient lithotripsy of renal calculi treated by PNL over the existing pneumatic intracorporeal lithotriptor the Swiss LithoClast.
Methods:
Patients would be recruited to the study from the clinical population who present for stone management at VGH. None of the physicians involved has a financial interest in either of the devices being evaluated. The purpose is to compare the pneumatic lithotripsy devices and is not an evaluation of PNL, a procedure whose safety and efficacy is well established.
Patients who consented to PNL for management of their renal stone would be approached about entry into the study by either of the primary surgeons, the research coordinator, or the research fellows. Patients would understand that PNL is not an experimental procedure and that the research project specifically is comparing the two lithotripsy devices with similar mechanism of action and safety profile. The goal in all cases would be to render the patient stone free. The patients care would not deviate from our standard PNL care protocol, summarized below, with the exception of the use of a different lithoclast.
Pre-operatively, the patients are assessed in the Preanaesthetic clinic as necessary. Blood tests including CBC and differential, blood type and antibody screen, creatinine and electrolytes are routinely obtained. Urine samples will be sent preoperatively for culture and sensitivity. If the urine culture is positive, organism specific antibiotics will be prescribed prior to treatment. If the urine culture is negative, prophylactic antibiotics will be ordered and administered, prior to the induction of anaesthesia, by the treating surgeon.
Our standard operative protocol for PNL as described next will be followed for all cases. After receiving a general anaesthetic, cystoscopy and placement of a ureteral catheter on the affected side may be performed. The will be used to perform retrograde pyelography in order to determine the optimal access site to the kidney. A Foley catheter will be placed to drain the bladder throughout the procedure. Next, under fluoroscopic guidance, access to the affected renal collecting system will be obtained with a needle down which a guide wire is passed by the interventional radiology department or the operating surgeon.
The tract will be dilated to accommodate the 30F working sheath. The stone will then be visualized and fragmented with either of the two devices, determined by randomization. Remaining fragments will be removed using grasping forceps and an ultrasound suction device until the patient is rendered stone free. A final visual inspection of the collecting system will ensure the patient is stone free. The choice of renal drainage method after the procedure will be left to the discretion of the treating surgeon.
Statistical Analysis: Student's t-test and ANOVA will be used to determine statistical significance. P-values < 0.05 will be considered significant.
- Conditions
- Percutaneous Nephrolithotripsy
- Being tested
- The stonebreaker arm (LMA Stonebreaker), Pneumatic Lithotripsy (Swiss LithoClastR)
- Keywords
- PNL, Lithoclast, Stonebreaker, efficiency stone fragmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The stonebreaker arm (LMA Stonebreaker)Device
The interventional device name is the LMA Stonebreaker pneumatic handheld lithotriptor.
Pneumatic Lithotripsy (Swiss LithoClastR)Device
Pneumatic lithotripsy, the Swiss LithoClastR during percutaneous nephrolithotripsy (PNL)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The LMA StoneBreakerTM Receives: Device: The stonebreaker arm (LMA Stonebreaker) |
| 2 | Active comparator | Pneumatic Lithotripsy Receives: Device: Pneumatic Lithotripsy (Swiss LithoClastR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete fragmentation of renal calculi treated via PNL
Measured: During surgery
Secondary outcomes (1)
Time to removal of large fragments using graspers & time required with US to remove small fragments/dust
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotripsyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- VGH and UBC Hospital Foundation, Vancouver Coastal Health
- Investigators
- Ben Chew, MD, FRCSC, Principal investigator, University of British ColumbiaR. Paterson, MD, Study director, University of British ColumbiaJ. Wright, MD, Study director, University of British ColumbiaJ. Teichman, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677196
- Sponsor's protocol ID
- H07-01887
- Status last verified
- Sep 2010
- First submitted
- 12 May 2008
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Canadian StoneBreakerTM Trial: A Randomized, Multicentre Trial Comparing The LMA StoneBreakerTM and the Swiss LithoClastR During Percutaneous Nephrolithotripsy.
- ClinicalTrials.gov ID
- NCT00677196
- Acronym / sponsor ID
- H07-01887
- Conditions
- Percutaneous Nephrolithotripsy
- Keywords
- PNL, Lithoclast, Stonebreaker, efficiency stone fragmentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- VGH and UBC Hospital Foundation, Vancouver Coastal Health
- Study start
- Feb 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 May 2008 (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.
The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).
Detailed description
Objective:
The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).
Rationale:
Percutaneous nephrolithotripsy (PNL) is the preferred treatment modality for renal stones greater than 2cm in diameter.
The pneumatic lithotriptor functions as a pneumatic jackhammer, providing either a single pulse or a train of pulses at 2Hz as determined by the operator. Its chief advantage is its ability to fragment even the hardest calculi. The pneumatic lithotriptor, while extremely effective, does not utilize thermal energy and therefore has no risk of thermal damage to the surrounding tissue. The pneumatic lithotriptor currently in use, the Swiss LithoClast is powered by compressed medical air. The primary disadvantage of this device is that the residual calculi must be individually removed with forceps following fragmentation.
The StoneBreaker, manufactured by the Laryngeal Mask Airway Company, is a novel hand-held pneumatic lithotriptor. This device is powered by a compressed carbon dioxide cartridge.
Hypothesis:
The LMA StoneBreaker, provides more efficient lithotripsy of renal calculi treated by PNL over the existing pneumatic intracorporeal lithotriptor the Swiss LithoClast.
Methods:
Patients would be recruited to the study from the clinical population who present for stone management at VGH. None of the physicians involved has a financial interest in either of the devices being evaluated. The purpose is to compare the pneumatic lithotripsy devices and is not an evaluation of PNL, a procedure whose safety and efficacy is well established.
Patients who consented to PNL for management of their renal stone would be approached about entry into the study by either of the primary surgeons, the research coordinator, or the research fellows. Patients would understand that PNL is not an experimental procedure and that the research project specifically is comparing the two lithotripsy devices with similar mechanism of action and safety profile. The goal in all cases would be to render the patient stone free. The patients care would not deviate from our standard PNL care protocol, summarized below, with the exception of the use of a different lithoclast.
Pre-operatively, the patients are assessed in the Preanaesthetic clinic as necessary. Blood tests including CBC and differential, blood type and antibody screen, creatinine and electrolytes are routinely obtained. Urine samples will be sent preoperatively for culture and sensitivity. If the urine culture is positive, organism specific antibiotics will be prescribed prior to treatment. If the urine culture is negative, prophylactic antibiotics will be ordered and administered, prior to the induction of anaesthesia, by the treating surgeon.
Our standard operative protocol for PNL as described next will be followed for all cases. After receiving a general anaesthetic, cystoscopy and placement of a ureteral catheter on the affected side may be performed. The will be used to perform retrograde pyelography in order to determine the optimal access site to the kidney. A Foley catheter will be placed to drain the bladder throughout the procedure. Next, under fluoroscopic guidance, access to the affected renal collecting system will be obtained with a needle down which a guide wire is passed by the interventional radiology department or the operating surgeon.
The tract will be dilated to accommodate the 30F working sheath. The stone will then be visualized and fragmented with either of the two devices, determined by randomization. Remaining fragments will be removed using grasping forceps and an ultrasound suction device until the patient is rendered stone free. A final visual inspection of the collecting system will ensure the patient is stone free. The choice of renal drainage method after the procedure will be left to the discretion of the treating surgeon.
Statistical Analysis: Student's t-test and ANOVA will be used to determine statistical significance. P-values < 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: The stonebreaker arm (LMA Stonebreaker)The LMA StoneBreakerTM |
| 2 | Active comparator | Device: Pneumatic Lithotripsy (Swiss LithoClastR)Pneumatic Lithotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over the age of 18 undergoing PNL
- Previously untreated renal stones
- Patients with 3 or less individual renal calculi, accessible with a rigid nephroscope
- Stones must be at least >225mm2 area on KUB
- Patient must have a CT scan prior to treatment
Key exclusion criteria (5 listed)
- Patients with an active contraindication for PNL (pregnancy, uncorrected coagulopathy, active urinary infection, contrast allergy)
- Partial staghorn calculi
- Complete staghorn calculi
- Stones in calyceal diverticulum
- Cases requiring multiple tracts
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 |
|---|---|---|
| The stonebreaker arm (LMA Stonebreaker)The interventional device name is the LMA Stonebreaker pneumatic handheld lithotriptor. | Device | 1 |
| Pneumatic Lithotripsy (Swiss LithoClastR)Pneumatic lithotripsy, the Swiss LithoClastR during percutaneous nephrolithotripsy (PNL) | Device | 2 |
Primary outcome
Time to complete fragmentation of renal calculi treated via PNL
Time frame: During surgery
1 secondary outcome
Time to removal of large fragments using graspers & time required with US to remove small fragments/dust
Time frame: During surgery
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 27 Sep 2010.
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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.
Ben Chew, MD, FRCSC principal investigator
University of British Columbia
R. Paterson, MD study director
University of British Columbia
J. Wright, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The stonebreaker arm (LMA Stonebreaker) and Pneumatic Lithotripsy (Swiss LithoClastR) in people with Percutaneous Nephrolithotripsy, run by University of British Columbia 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 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: finished, as of the sponsor's last update on 27 Sep 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to complete fragmentation of renal calculi treated via PNL (time frame: During surgery). 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 27 Sep 2010.