Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-30 @ 12:41 PM
Study NCT ID:
NCT01604304
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2012-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002137', 'term': 'Calculi'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008096', 'term': 'Lithotripsy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-22', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone free rate', 'timeFrame': 'Three months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Stone free rate in weight's sub group", 'timeFrame': '3 months', 'description': "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"}, {'measure': 'Stone free rate in sub group depending on stone diameters', 'timeFrame': '3 months', 'description': "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"}, {'measure': 'Secondary procedure rate', 'timeFrame': '3 months', 'description': 'In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate'}, {'measure': 'Serious and non serious adverse events', 'timeFrame': '3 months', 'description': 'In each arm will be evaluate rate of adverse event, type, severity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stone', 'calculi', 'kidney', 'renal treatment', 'flexible ureteroscopy', 'extracoporeal shockwave lithotripsy', 'retrograde intra renal surgery'], 'conditions': ['Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy']}, 'referencesModule': {'references': [{'pmid': '25640027', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with 5 to 20 mm renal stone\n* Age ≥ 18 years old\n* Patient agreement signed\n* BMI \\< 35\n* Contraception\n\nExclusion Criteria:\n\n* Pregnancy\n* Severe musculoskeletal deformities\n* Renal artery or aorta aneurysm\n* Pacemaker\n* Anesthesia contra indication\n* Psychiatric trouble or law protection'}, 'identificationModule': {'nctId': 'NCT01604304', 'acronym': 'CALIX-1', 'briefTitle': 'Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '2011.692'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporeal shockwave lithotripsy', 'description': 'stone treatment using electroconductive technology', 'interventionNames': ['Procedure: extracorporeal shockwave lithotripsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flexible ureteroscopy', 'description': 'intra renal retrograde surgery with or without laser and stone extraction', 'interventionNames': ['Procedure: flexible ureteroscopy']}], 'interventions': [{'name': 'flexible ureteroscopy', 'type': 'PROCEDURE', 'description': 'Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.', 'armGroupLabels': ['Flexible ureteroscopy']}, {'name': 'extracorporeal shockwave lithotripsy', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Extracorporeal shockwave lithotripsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69 003', 'city': 'Lyon', 'country': 'France', 'facility': "Service d'urologie, Hôpital Edouard Herriot", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Xavier Martin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}