Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi (CALIX-1)
This study is currently recruiting participants.
Verified April 2012 by Hospices Civils de Lyon
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01604304
First received: May 21, 2012
Last updated: February 5, 2013
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy |
Procedure: flexible ureteroscopy Procedure: extracorporeal shockwave lithotripsy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial |
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- Stone free rate [ Time Frame: Three months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Stone free rate in weight's sub group [ Time Frame: 3 months ] [ Designated as safety issue: No ]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
- Stone free rate in sub group depending on stone diameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]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
- Secondary procedure rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate
- Serious and non serious adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]In each arm will be evaluate rate of adverse event, type, severity.
| Estimated Enrollment: | 180 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Extracorporeal shockwave lithotripsy
stone treatment using electroconductive technology
|
Procedure: extracorporeal shockwave lithotripsy
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
|
|
Active Comparator: Flexible ureteroscopy
intra renal retrograde surgery with or without laser and stone extraction
|
Procedure: flexible ureteroscopy
Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604304
Contacts
| Contact: Xavier Martin, PhD | 4 72 11 91 91 ext +33 | xavier.martin@chu-lyon.fr |
Locations
| France | |
| Service d'urologie, Hôpital Edouard Herriot | Recruiting |
| Lyon, France, 69 003 | |
| Contact: Xavier MARTIN, PhD 4 72 11 91 91 ext +33 xavier.martin@chu-lyon.fr | |
| Principal Investigator: Xavier MARTIN, PhD | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Xavier Martin, PhD | Hospices Civils de Lyon |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01604304 History of Changes |
| Other Study ID Numbers: | 2011.709 |
| Study First Received: | May 21, 2012 |
| Last Updated: | February 5, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
stone calculi kidney renal treatment |
flexible ureteroscopy extracoporeal shockwave lithotripsy retrograde intra renal surgery |
Additional relevant MeSH terms:
|
Calculi Kidney Calculi Pathological Conditions, Anatomical Nephrolithiasis |
Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi |
ClinicalTrials.gov processed this record on May 16, 2013