Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 1:21 AM
Study NCT ID:
NCT00802750
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Where Healthy Volunteers Evaluate LoFric Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-05-13', 'releaseDate': '2021-04-20'}], 'estimatedResultsFirstSubmitDate': '2021-04-20'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2008-12-04', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthy volunteers perception of catheterization', 'timeFrame': 'At each catheterization (three times during one day)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Catheterization']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day.\n\nThe hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of written informed consent\n* Healthy volunteers\n* Males age 18 years and over\n\nExclusion Criteria:\n\n* Known or suspected, current impairment of and/or decreased urethral sensibility\n* History of urethral disease\n* History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection\n* Use of medications that may affect the urethra's dryness (e. g. anti-cholinergic drugs or cortisone)\n* Current drug, alcohol or other substance abuse\n* Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation\n* Allergy to Trimethoprim\n* Suspected poor compliance with the protocol during the complete study period."}, 'identificationModule': {'nctId': 'NCT00802750', 'briefTitle': 'Study Where Healthy Volunteers Evaluate LoFric Catheters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wellspect HealthCare'}, 'officialTitle': 'A Randomized, Single-blind, Cross-over, Single Centre Study in Healthy Volunteers Evaluating Subject Perception of Urinary Catheters Manufactured in a New Process With New Solvent', 'orgStudyIdInfo': {'id': 'YA-LSM-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Device: LoFric POBE']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Device: LoFric POBE']}], 'interventions': [{'name': 'LoFric POBE', 'type': 'DEVICE', 'description': 'LoFric POBE, Nelaton 40 cm, CH 12 with new solvent. Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters.', 'armGroupLabels': ['A']}, {'name': 'LoFric POBE', 'type': 'DEVICE', 'description': 'Unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with new solvent Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Clinical Research and Trial Centre, Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Ulf Malmqvist, MD, PhD, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research and Trial Centre, Lund University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wellspect HealthCare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-04-20', 'type': 'RELEASE'}, {'date': '2021-05-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Wellspect HealthCare'}}}}