Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT00250406
Status:
COMPLETED
Last Update Posted:
2013-12-20
First Post:
2005-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D014517', 'term': 'Ureteral Obstruction'}, {'id': 'D052878', 'term': 'Urolithiasis'}], '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': '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': 'D014515', 'term': 'Ureteral Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-19', 'studyFirstSubmitDate': '2005-11-04', 'studyFirstSubmitQcDate': '2005-11-04', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary objective is to determine if the number of stent adherent bacteria will be less in patients who receive a triclosan stent compared to a control/standard stent.', 'timeFrame': 'at time of intervention'}], 'secondaryOutcomes': [{'measure': "Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.", 'timeFrame': 'at time of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urolithiasis', 'ureteral stent', 'triclosan', 'drug eluting'], 'conditions': ['Renal Calculi', 'Ureteral Obstruction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the clinical effects of a triclosan stent on adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling triclosan ureteral stent. The patient populations that will be tested include: patients following ureteroscopy and patients scheduled to undergo shockwave lithotripsy who require a ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who undergo ureteroscopy for any reason and require a ureteral stent post-operatively as determined by the surgeon (e.g. renal obstruction, ureteral edema, ureteral perforation, large stone fragments to pass, following ureteral dilation, ureteral trauma, solitary kidney, or any other reason left to the discretion of the surgeon).\n* Patients undergoing extracorporeal shockwave lithotripsy (ESWL) who will require a stent as determined by the treating urologist (e.g. solitary kidney, ureteral stone \\> 1 cm, renal stone \\> 1.5 cm, significant renal obstruction, history of pyelonephritis, or any other reason left to the discretion of the surgeon).\n* Patients who have or are going to have chronic ureteral stents, for any reason.\n* Patients willing to return to St. Joseph's Hospital's Urology Clinic for follow-up.\n\nExclusion Criteria:\n\n* Age ≤ 17 years\n* Patients unable to consent.\n* Any patient requiring endocarditis or prosthetic device prophylaxis (e.g. fresh arthroplasty etc.).\n* Pregnant females\n* Immunocompromised patients\n* Significant urinary symptoms (urgency, dysuria, strangury, hematuria) or other bladder pathology that may cause these symptoms (e.g. interstitial cystitis)\n* Anyone in the investigator's opinion that would be unsuitable."}, 'identificationModule': {'nctId': 'NCT00250406', 'briefTitle': 'Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study', 'orgStudyIdInfo': {'id': 'R-05-646'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Percuflex Plus Ureteral Stent', 'interventionNames': ['Device: Ureteral Stent']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'TRIUMPH stent (triclosan-eluting stent)', 'interventionNames': ['Device: Ureteral Stent']}], 'interventions': [{'name': 'Ureteral Stent', 'type': 'DEVICE', 'otherNames': ['TRIUMPH STENT'], 'description': 'triclosan-eluting ureteral stent', 'armGroupLabels': ['2']}, {'name': 'Ureteral Stent', 'type': 'DEVICE', 'otherNames': ['Percuflex Plus Stent'], 'description': 'Percuflex Plus Stent as the control', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "Urology, St. Joseph's Hospital", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'John D Denstedt, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Hospital, The University of Western Ontario"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair/Chief, Department of Surgery, Western University', 'investigatorFullName': 'John Denstedt', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}