Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 1:53 AM
Study NCT ID:
NCT01008267
Status:
UNKNOWN
Last Update Posted:
2009-11-05
First Post:
2009-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shockwave Lithotripsy (SWL) Under Selective, General Anesthesia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D014514', 'term': 'Ureteral Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D014515', 'term': 'Ureteral Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2009-11-04', 'studyFirstSubmitDate': '2009-11-04', 'studyFirstSubmitQcDate': '2009-11-04', 'lastUpdatePostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Renal Calculi', 'Ureteral Calculi']}, 'descriptionModule': {'briefSummary': 'SWL is widely used in the treatment of patients with renal and ureteral calculi. Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: stone size, stone location within the collecting system, stone type, and the SWL machine used. Moreover, in some cases it is very difficult to focus on the stone because of its movement as a results of breathing. In order to prevent stone movement we want to use a bronchial blocker, processing a selective ventilation of the opposite side of stone location.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who failed in SWL process taken under sedation (standard protocol)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years old\n* Not pregnant\n* All patients who failed in SWL process, taken under sedation (standard protocol)\n\nExclusion Criteria:\n\n* Age \\< 18\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01008267', 'briefTitle': 'Shockwave Lithotripsy (SWL) Under Selective, General Anesthesia.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Shockwave Lithotripsy (SWL) Under Regular General Anesthesia and Under General Anesthesia Using Bronchial Blocker.', 'orgStudyIdInfo': {'id': '63/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SWL under general anesthesia', 'description': 'Patients who failed in SWL under sedation(a standard protocol), will undergo a second SWL process under general anesthesia.'}, {'label': 'SWL under general selective anesthesia', 'description': 'Patients who failed in SWL under sedation(a standard protocol), will undergo a second SWL process under general selective anesthesia, using a bronchial blocker.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Beer-Yaakov, Zrifin', 'country': 'Israel', 'contacts': [{'name': 'Zoya Haitov, MD', 'role': 'CONTACT', 'email': 'ZoyaC@asaf.health.gov.il', 'phone': '089778080'}, {'name': 'Zoya Haitov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anesthesiology department, Assaf-Harofeh MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Zoya Haitov MD', 'oldOrganization': 'Anesthesiology department, Assaf-Harofeh Medical Center'}}}}