Kidney StonesPhase 3NCT00959153
Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney
A Phase 3 study testing LithoSpace Extracorporeal Shockwave Lithotripter in people with Kidney Stones, run by Advance Shockwave Technology GmbH at 2 sites in United States.
Trial summary
A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones
- What is being tested?
- LithoSpace Extracorporeal Shockwave Lithotripter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Aug 2011
- 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
- Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter
- Presence of one stone greater than 4 mm and less than 12 mm
Who cannot join
- Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system
- Impaction of stone to be treated
- Staghorn stones
- Failed or inadequate lithotripsy procedure within 3 months prior to study
- Coagulation abnormalities or anticoagulation therapy
- Pregnant or females of child-bearing potential General, spinal or epidural anesthesia is contraindicated
- Can not be positioned correctly for fluoroscopic imaging
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Metropolitan Lithotriptor Associates
Garden City, New York, 11530
Allied Urological Services, LLC
New York, New York, 10016
About this study
Official title: Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)
A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.
- Conditions
- Kidney Stones
- Being tested
- LithoSpace Extracorporeal Shockwave Lithotripter
- Keywords
- Fragmenting of kidney stones, extracorporeal shockwave lithotripsy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithoSpace Extracorporeal Shockwave LithotripterDevice
Shockwave therapy to break up kidney stones
| Study group | Role | What they receive |
|---|---|---|
| Kidney stones | Experimental | Kidney stones Receives: Device: LithoSpace Extracorporeal Shockwave Lithotripter |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone fragmentation
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJun 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advance Shockwave Technology GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959153
- Sponsor's protocol ID
- G080108
- Status last verified
- May 2011
- First submitted
- 11 Aug 2009
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)
- ClinicalTrials.gov ID
- NCT00959153
- Acronym / sponsor ID
- G080108
- Conditions
- Kidney Stones
- Keywords
- Fragmenting of kidney stones, extracorporeal shockwave lithotripsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Advance Shockwave Technology GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 14 Aug 2009 (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.
A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney stones | Experimental | Device: LithoSpace Extracorporeal Shockwave LithotripterKidney stones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter
- Presence of one stone greater than 4 mm and less than 12 mm
Key exclusion criteria (7 listed)
- Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system
- Impaction of stone to be treated
- Staghorn stones
- Failed or inadequate lithotripsy procedure within 3 months prior to study
- Coagulation abnormalities or anticoagulation therapy
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 |
|---|---|---|
| LithoSpace Extracorporeal Shockwave LithotripterShockwave therapy to break up kidney stones | Device | Kidney stones |
Primary outcome
stone fragmentation
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LithoSpace Extracorporeal Shockwave Lithotripter in people with Kidney Stones, run by Advance Shockwave Technology GmbH at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Results are not available in the source record.
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 fragmentation (time frame: 14 days). 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 1 Jun 2011.