Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy Clinical Trial
— CALIX-1Official title:
Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial
| NCT number | NCT01604304 |
| Other study ID # | 2011.692 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2012 |
| Est. completion date | February 2014 |
| Verified date | August 2014 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient with 5 to 20 mm renal stone - Age = 18 years old - Patient agreement signed - BMI < 35 - Contraception Exclusion Criteria: - Pregnancy - Severe musculoskeletal deformities - Renal artery or aorta aneurysm - Pacemaker - Anesthesia contra indication - Psychiatric trouble or law protection |
| Country | Name | City | State |
|---|---|---|---|
| France | Service d'urologie, Hôpital Edouard Herriot | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | 3 months | |
| Secondary | 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 | 3 months | |
| Secondary | Secondary procedure rate | In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate | 3 months | |
| Secondary | Serious and non serious adverse events | In each arm will be evaluate rate of adverse event, type, severity. | 3 months |