Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-01-08 @ 4:55 AM
Study NCT ID:
NCT03628833
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2018-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incontinence Management System ICU Field Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D005242', 'term': 'Fecal 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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Staff satisfaction surveys on product performance', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'Following product use, staff can complete an optional, Likert scale survey'}], 'secondaryOutcomes': [{'measure': 'Patient exposure time following an incontinence event', 'timeFrame': 'Through study completion, an average of 4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with urinary, fecal, or dual incontinence who are ≥ 18 years old\n* The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent\n\nExclusion Criteria:\n\n\\- Patients that are considered to be near death or require palliative care"}, 'identificationModule': {'nctId': 'NCT03628833', 'briefTitle': 'Incontinence Management System ICU Field Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hill-Rom'}, 'officialTitle': 'Hill-Rom Incontinence Management System ICU Field Evaluation', 'orgStudyIdInfo': {'id': 'CR-CWS2018-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Incontinence Management system', 'interventionNames': ['Device: Incontinence Management System']}], 'interventions': [{'name': 'Incontinence Management System', 'type': 'DEVICE', 'description': 'Incontinence detection device', 'armGroupLabels': ['Incontinence Management system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Saint Joseph Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hill-Rom', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}