Kidney StonesNCT01514032
Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones
A study testing Extracorporal shockwave lithotripsy and Retrograde intrarenal surgery in people with Kidney Stones, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative. Trial with surgical intervention 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?
- Extracorporal shockwave lithotripsy and Retrograde intrarenal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2011to Feb 2014
- 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
None listed.
Who cannot join
- pregnancy
- breastfeeding mother
- disorders of blood clotting
- kidneystones > 15mm
- aneurysms of the aorta or renal artery
- severe skeletal deformations which hamper one of the treatment modalities
- synchronous stones of the ipsilateral ureter
- stones which can not visualized which X-ray or sonography
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Urology
Zurich
About this study
Official title: TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery
The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.
- Trial with surgical intervention
- Conditions
- Kidney Stones
- Being tested
- Extracorporal shockwave lithotripsy, Retrograde intrarenal surgery
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporal shockwave lithotripsyProcedure or surgery
Extracorporal shockwave lithotripsy
Retrograde intrarenal surgeryProcedure or surgery
Retrograde intrarenal surgery
| Study group | Role | What they receive |
|---|---|---|
| Extracorporal shockwave lithotripsy | Active comparator | Not described Receives: Procedure: Extracorporal shockwave lithotripsy |
| Retrograde intrarenal surgery | Active comparator | Not described Receives: Procedure: Retrograde intrarenal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
stonefree-rates 3month after therapy
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (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.
- More trials run by University of ZurichThe 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital ZuerichMichael Muentener, MD, Principal investigator, University Hospital Zurich, Division of urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514032
- Sponsor's protocol ID
- TOP-Stone
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT01514032
- Acronym / sponsor ID
- TOP-Stone
- Conditions
- Kidney Stones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 20 Jan 2012 (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 two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.
- Trial with surgical intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporal shockwave lithotripsy | Active comparator | Procedure: Extracorporal shockwave lithotripsy |
| Retrograde intrarenal surgery | Active comparator | Procedure: Retrograde intrarenal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- pregnancy
- breastfeeding mother
- disorders of blood clotting
- kidneystones > 15mm
- aneurysms of the aorta or renal artery
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 |
|---|---|---|
| Extracorporal shockwave lithotripsyExtracorporal shockwave lithotripsy | Procedure or surgery | Extracorporal shockwave lithotripsy |
| Retrograde intrarenal surgeryRetrograde intrarenal surgery | Procedure or surgery | Retrograde intrarenal surgery |
Primary outcome
stonefree-rates 3month after therapy
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
Michael Muentener, MD principal investigator
University Hospital Zurich, Division of urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporal shockwave lithotripsy and Retrograde intrarenal surgery in people with Kidney Stones, run by University of Zurich at 1 site in Switzerland.
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 0 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: status not confirmed, as of the sponsor's last update on 20 Jan 2012. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damian Weber, MD (+41 44 2555407, damian.weber@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stonefree-rates 3month after therapy (time frame: 3 month). 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 Jan 2012.