Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi
CALIX-1
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMay 28, 2019
August 1, 2014
1.8 years
May 21, 2012
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Three months
Secondary Outcomes (4)
Stone free rate in weight's sub group
3 months
Stone free rate in sub group depending on stone diameters
3 months
Secondary procedure rate
3 months
Serious and non serious adverse events
3 months
Study Arms (2)
Extracorporeal shockwave lithotripsy
ACTIVE COMPARATORstone treatment using electroconductive technology
Flexible ureteroscopy
ACTIVE COMPARATORintra renal retrograde surgery with or without laser and stone extraction
Interventions
Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.
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
Eligibility Criteria
You may qualify if:
- Patient with 5 to 20 mm renal stone
- Age ≥ 18 years old
- Patient agreement signed
- BMI \< 35
- Contraception
You may not qualify if:
- Pregnancy
- Severe musculoskeletal deformities
- Renal artery or aorta aneurysm
- Pacemaker
- Anesthesia contra indication
- Psychiatric trouble or law protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'urologie, Hôpital Edouard Herriot
Lyon, 69 003, France
Related Publications (1)
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.
PMID: 25640027RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier Martin, PhD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
May 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
May 28, 2019
Record last verified: 2014-08