Kidney StonesNCT00952315
Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery
A study testing Cyberwand, Stonebreaker and Lithoclast Select in people with Kidney Stones, run by Indiana Kidney Stone Institute at 10 sites in 2 countries.
Trial summary
The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others. 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?
- Cyberwand, Stonebreaker and Lithoclast Select
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Aug 2009to Feb 2017
- 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
- Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater
- Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively
- Age 18 years or older
- Able to give informed consent
Who cannot join
- Size of single largest stone less than 2 cm
- Pregnancy
- Active urinary tract infection
- Extracorporeal shockwave lithotripsy within the last three months
- Complex stone anticipating multiple access sites
- Stones that are not clearly able to be measured on KUB or CT scan
- Inability to give informed consent
- Age less than 18 years
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Johns Hopkins
Baltimore, Maryland, 21224
Northwestern University
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
IU Health Physicians Urology
Indianapolis, Indiana, 46202
University of Wisconsin
Madison, Wisconsin, 53792
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mayo Clinic Scottsdale
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Canada2 sites
The University of Western Ontario
London, Ontario, N6A 4V2
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.
Read the detailed description
Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages.
In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges.
We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.
- Conditions
- Kidney Stones
- Being tested
- Cyberwand, Stonebreaker, Lithoclast Select
- Keywords
- kidney stones, intracorporeal lithotriptors, kidney stone removal
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberwandDevice
Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
StonebreakerDevice
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
Lithoclast SelectDevice
Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
| Study group | Role | What they receive |
|---|---|---|
| Stonebreaker | Active comparator | Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. Receives: Device: Stonebreaker |
| Lithoclast Select | Active comparator | Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. Receives: Device: Lithoclast Select |
| Cyberwand | Active comparator | The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. Receives: Device: Cyberwand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Clearance Time in mm2/Min
Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)
Measured: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
Secondary outcomes (9)
Stone-free After First Procedure
Number of participants deemed stone-free after initial stone-removal surgery
Measured: Post-operative Day 1
Secondary Procedure Required
Number of participants who required a secondary kidney stone removal procedure
Measured: Within three days of initial procedure
Ureteral Stent Placed
Participants requiring a ureteral stent to be placed after initial stone removal procedure
Measured: Intra-operatively
Nephrostomy Tube Placed
Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure
Measured: Intra-operatively
Use of Other Device
Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite
Measured: Intra-operatively
EBL>400mL
Number of participants with an estimated blood loss greater than 400mL
Measured: Intra-operatively
RBC Transfusion
Number of participants who required a blood transfusion post-operatively
Measured: Post-operatively <24 hours
Length of Stay
Number of days participants were in hospital. Operative day is Day 1.
Measured: Post-operatively
Post-operative Complications
Number of participants who experienced surgery-related post-op complications
Measured: Post-operative Days 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2016
- Study completionFeb 2017
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 Kidney StonesStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Kidney Stone Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Lingeman, Indiana Kidney Stone Institute
- Investigators
- James E Lingeman, MD, Principal investigator, IU Health Physicians Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952315
- Sponsor's protocol ID
- 09-045
- Status last verified
- Jun 2019
- First submitted
- 3 Aug 2009
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
- ClinicalTrials.gov ID
- NCT00952315
- Acronym / sponsor ID
- 09-045
- Conditions
- Kidney Stones
- Keywords
- kidney stones, intracorporeal lithotriptors, kidney stone removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Indiana Kidney Stone InstituteUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.
Detailed description
Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages.
In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges.
We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stonebreaker | Active comparator | Device: StonebreakerStonebreaker will be used to break up the kidney stone. Duration will be timed and documented. |
| Lithoclast Select | Active comparator | Device: Lithoclast SelectLithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. |
| Cyberwand | Active comparator | Device: CyberwandThe dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater
- Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively
- Age 18 years or older
- Able to give informed consent
Key exclusion criteria (8 listed)
- Size of single largest stone less than 2 cm
- Pregnancy
- Active urinary tract infection
- Extracorporeal shockwave lithotripsy within the last three months
- Complex stone anticipating multiple access sites
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 |
|---|---|---|
| CyberwandDual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented. | Device | Cyberwand |
| StonebreakerStonebreaker will be used to break up the kidney stone. Duration will be timed and documented. | Device | Stonebreaker |
| Lithoclast SelectLithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented | Device | Lithoclast Select |
Primary outcome
Stone Clearance Time in mm2/Min
Time frame: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)
9 secondary outcomes
Stone-free After First Procedure
Time frame: Post-operative Day 1
Secondary Procedure Required
Time frame: Within three days of initial procedure
Ureteral Stent Placed
Time frame: Intra-operatively
Nephrostomy Tube Placed
Time frame: Intra-operatively
Use of Other Device
Time frame: Intra-operatively
EBL>400mL
Time frame: Intra-operatively
RBC Transfusion
Time frame: Post-operatively <24 hours
Length of Stay
Time frame: Post-operatively
Post-operative Complications
Time frame: Post-operative Days 2 and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- International Kidney Stone Institute - Click here for more information about kidney stone diseaseLink provided by the sponsor.
- 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.
James E Lingeman, MD principal investigator
IU Health Physicians Urology
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyberwand, Stonebreaker and Lithoclast Select in people with Kidney Stones, run by Indiana Kidney Stone Institute at 10 sites in 2 countries.
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 4 inclusion and 8 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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?
Yes. Results are posted in the registry (first posted 5 Jul 2019). 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?
Stone Clearance Time in mm2/Min (time frame: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket). 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 5 Jul 2019.