Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02965105
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2016-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2016-11-11', 'studyFirstSubmitQcDate': '2016-11-11', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '1 day', 'description': 'Pain experienced by the subjects at catheterisation is measure with the VAS scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Incontinence, Urinary']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to test the performance and safety of a newly developed intermittent catheter'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. Have a negative urine multistix:\n\n * Leukocytes\n * Nitrite Or if positive, subsequent negative for bacterial growth in urine culture\n\nExclusion Criteria:\n\n1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract\n2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)\n3. Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation\n4. Known hypersensitivity toward any of the test products -'}, 'identificationModule': {'nctId': 'NCT02965105', 'briefTitle': 'Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CP271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First Coloplast Test Catheter; then Speedicath', 'description': 'The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter', 'interventionNames': ['Device: Coloplast Test Catheter', 'Device: Speedicath']}, {'type': 'EXPERIMENTAL', 'label': 'First Speedicath; then Coloplast Test Catheter', 'description': 'The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter', 'interventionNames': ['Device: Coloplast Test Catheter', 'Device: Speedicath']}], 'interventions': [{'name': 'Coloplast Test Catheter', 'type': 'DEVICE', 'description': 'This is a newly developed intermittent catheter', 'armGroupLabels': ['First Coloplast Test Catheter; then Speedicath', 'First Speedicath; then Coloplast Test Catheter']}, {'name': 'Speedicath', 'type': 'DEVICE', 'description': 'This is a marketed Catheter which is used as comparator', 'armGroupLabels': ['First Coloplast Test Catheter; then Speedicath', 'First Speedicath; then Coloplast Test Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'København Ø', 'country': 'Denmark', 'facility': 'Rigshopsitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Per Bagi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD at the clinic for urology at Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}