Extracorporeal Shockwave Lithotripsy, Flexible UreteroscopyCALIX-1NCT01604304
Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi
A study testing flexible ureteroscopy and extracorporeal shockwave lithotripsy in people with Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy
- What is being tested?
- flexible ureteroscopy and extracorporeal shockwave lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to 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
- Patient with 5 to 20 mm renal stone
- Age ≥ 18 years old
- Patient agreement signed
- BMI < 35
- Contraception
Who cannot join
- Pregnancy
- Severe musculoskeletal deformities
- Renal artery or aorta aneurysm
- Pacemaker
- Anesthesia contra indication
- Psychiatric trouble or law protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial
Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.
- Being tested
- flexible ureteroscopy, extracorporeal shockwave lithotripsy
- Keywords
- stone, calculi, kidney, renal treatment, flexible ureteroscopy, extracoporeal shockwave lithotripsy, retrograde intra renal surgery
- Medical subject headings
- Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible ureteroscopyProcedure or surgery
Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.
extracorporeal shockwave lithotripsyProcedure or surgery
The lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shockwave lithotripsy | Active comparator | stone treatment using electroconductive technology Receives: Procedure: extracorporeal shockwave lithotripsy |
| Flexible ureteroscopy | Active comparator | intra renal retrograde surgery with or without laser and stone extraction Receives: Procedure: flexible ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Rate of stone free patient or patient with residual fragment ≤ 3 mm, 3 months after the treatment evaluated, will be compare. This outcome is measured with a tomodensitometry and compares with pre treatment exams.
Measured: Three months
Secondary outcomes (4)
Stone free rate in weight's sub group
Each arm wil be divise in 3 sub group based on body mass index (20 to 25, 25 to 30, 30 to 35). We'll compare rate of efficacity in each sub group
Measured: 3 months
Stone free rate in sub group depending on stone diameters
Each arm wil be divise in 3 sub group based on calculi diameter (5 to 10mm, 10 to 15 and 15 to 20). We'll compare rate of efficacity in each sub group
Measured: 3 months
Secondary procedure rate
In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate
Measured: 3 months
Serious and non serious adverse events
In each arm will be evaluate rate of adverse event, type, severity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Shockwave Lithotripsy, Flexible UreteroscopyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Martin, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604304
- Sponsor's protocol ID
- 2011.692
- Acronym
- CALIX-1
- Status last verified
- Aug 2014
- First submitted
- 21 May 2012
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ravier E, Abid N, Ruffion A, Fassi-Fehri H, Buron C, Ganne C, Mallet A, Martin X. [Effectiveness of flexible ureteroscopy versus extracorporeal shock wave lithotripsy for kidney stones treatment]. Prog Urol. 2015 Apr;25(5):233-9. doi: 10.1016/j.purol.2015.01.005. Epub 2015 Jan 29. French.
PubMed 25640027
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01604304
- Acronym / sponsor ID
- CALIX-1 / 2011.692
- Keywords
- stone, calculi, kidney, renal treatment, flexible ureteroscopy, extracoporeal shockwave lithotripsy, retrograde intra renal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 May 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.
Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shockwave lithotripsy | Active comparator | Procedure: extracorporeal shockwave lithotripsystone treatment using electroconductive technology |
| Flexible ureteroscopy | Active comparator | Procedure: flexible ureteroscopyintra renal retrograde surgery with or without laser and stone extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with 5 to 20 mm renal stone
- Age ≥ 18 years old
- Patient agreement signed
- BMI < 35
- Contraception
Key exclusion criteria (6 listed)
- Pregnancy
- Severe musculoskeletal deformities
- Renal artery or aorta aneurysm
- Pacemaker
- Anesthesia contra indication
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 |
|---|---|---|
| flexible ureteroscopyFlexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique. | Procedure or surgery | Flexible ureteroscopy |
| extracorporeal shockwave lithotripsyThe lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken | Procedure or surgery | Extracorporeal shockwave lithotripsy |
Primary outcome
Stone free rate
Time frame: Three months
Rate of stone free patient or patient with residual fragment ≤ 3 mm, 3 months after the treatment evaluated, will be compare. This outcome is measured with a tomodensitometry and compares with pre treatment exams.
4 secondary outcomes
Stone free rate in weight's sub group
Time frame: 3 months
Stone free rate in sub group depending on stone diameters
Time frame: 3 months
Secondary procedure rate
Time frame: 3 months
Serious and non serious adverse events
Time frame: 3 months
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 28 May 2019.
- Results publication: PubMed 25640027Ravier E, Abid N, Ruffion A, Fassi-Fehri H, Buron C, Ganne C, Mallet A, Martin X. [Effectiveness of flexible ureteroscopy versus extracorporeal shock wave lithotripsy for kidney stones treatment]. Prog Urol. 2015 Apr;25(5):233-9. doi: 10.1016/j.purol.2015.01.005. Epub 2015 Jan 29. French.
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Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy
Kidney Stones
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.
Xavier Martin, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flexible ureteroscopy and extracorporeal shockwave lithotripsy in people with Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy, run by Hospices Civils de Lyon at 1 site in France.
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 6 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 28 May 2019. 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 France. 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?
Stone free rate (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01604304, which also lists 1 linked publication.
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 28 May 2019.