Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-10 @ 12:39 PM
Study NCT ID:
NCT02709395
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2016-02-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055496', 'term': 'Neurogenic Bowel'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'markus.wittebo@wellspect.com', 'phone': '+46 31 376 40 00', 'title': 'Head of Medical Affairs, Markus Wittebo', 'organization': 'Wellspect HealthCare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The safety of Navina Smart, e.g. registration of Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs), were collected throughout the study period for 4 weeks of each participating subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Navina Smart', 'description': 'Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).\n\nNavina Smart: Transanal irrigation at the same frequency as subject used before enrollment.', 'otherNumAtRisk': 28, 'otherNumAffected': 3, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Broke left leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Skin infection elbow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Questionnaire Measuring Subjects' Satisfaction of Navina Smart", 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navina Smart', 'description': 'Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).\n\nNavina Smart: Transanal irrigation at the same frequency as subject used before enrollment.'}], 'classes': [{'categories': [{'title': 'Answer missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject\'s assessment of satisfaction when using the study device.\n\nSatisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat Analysis Set'}, {'type': 'PRIMARY', 'title': "Questionnaire Measuring Subjects' Perception of Navina Smart", 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navina Smart', 'description': 'Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).\n\nNavina Smart: Transanal irrigation at the same frequency as subject used before enrollment.'}], 'classes': [{'categories': [{'title': 'Answer missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Neutral, satisfied or very satisfied with Navina', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Not satisfied with Navina', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject\'s assessment of perception when using the study device.\n\nFor example, each subject answered the following question regarding perception: "How satisfied are you with the Navina Smart System?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat Analysis Set'}, {'type': 'PRIMARY', 'title': "Questionnaire Measuring Subjects' Compliance of Navina Smart", 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navina Smart', 'description': 'Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).\n\nNavina Smart: Transanal irrigation at the same frequency as subject used before enrollment.'}], 'classes': [{'categories': [{'title': 'Answer missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject\'s compliance towards the study device.\n\nFor example, each subject answered the following question "Did you use the Navina Smart system for 4 weeks?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navina Smart', 'description': 'Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).\n\nNavina Smart: Transanal irrigation at the same frequency as subject used before enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient.', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Navina Smart', 'description': 'Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).\n\nNavina Smart: Transanal irrigation at the same frequency as subject used before enrollment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '28 subjects enrolled and found to be eligible for further study participation after screening.', 'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Navina Smart', 'description': 'Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).\n\nNavina Smart: Transanal irrigation at the same frequency as subject used before enrollment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.17', 'groupId': 'BG000', 'lowerLimit': '24.06', 'upperLimit': '72.79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bowel Management at Baseline - Satisfaction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not Satisfied - Not satisfied at all', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Neutral', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Satisfied - Completely satisfied', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Baseline Questionnaire is a study-specific, non-validated instrument, developed by Wellspect HealthCare. The Baseline Questionnaire is self-administered and was completed by the subjects at Visit 1.', 'unitOfMeasure': 'Participants'}, {'title': 'TAI therapy at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Peristeen', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Baseline Questionnaire is a study-specific, non-validated instrument, developed by Wellspect HealthCare. The Baseline Questionnaire is self-administered and was completed by the subjects at Visit 1.', 'unitOfMeasure': 'Participants'}, {'title': 'Time spent bowel management at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54.90', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '270'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: The Baseline Questionnaire is a study-specific, non-validated instrument, developed by Wellspect HealthCare. The Baseline Questionnaire is self-administered and was completed by the subjects at Visit 1.', 'unitOfMeasure': 'minutes', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data missing for 4 subjects, no response received'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2016-02-25', 'resultsFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2016-03-10', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-28', 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Questionnaire Measuring Subjects' Satisfaction of Navina Smart", 'timeFrame': '4 weeks', 'description': 'PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject\'s assessment of satisfaction when using the study device.\n\nSatisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?"'}, {'measure': "Questionnaire Measuring Subjects' Perception of Navina Smart", 'timeFrame': '4 weeks', 'description': 'PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject\'s assessment of perception when using the study device.\n\nFor example, each subject answered the following question regarding perception: "How satisfied are you with the Navina Smart System?"'}, {'measure': "Questionnaire Measuring Subjects' Compliance of Navina Smart", 'timeFrame': '4 weeks', 'description': 'PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject\'s compliance towards the study device.\n\nFor example, each subject answered the following question "Did you use the Navina Smart system for 4 weeks?"'}], 'secondaryOutcomes': [{'measure': 'Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart', 'timeFrame': '4 weeks', 'description': 'Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neurogenic Bowel']}, 'descriptionModule': {'briefSummary': 'This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of informed consent\n2. Males and females, aged 18 years and over\n3. Practice TAI since at least 2 months and at least two times per week\n4. Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator\n\nExclusion Criteria:\n\n1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions\n2. Untreated rectal impaction\n3. Any radiotherapy to the pelvis\n4. Any current treatment with anticoagulants (not including aspirin or clopidogrel)\n5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)\n6. Any prior rectal or colonic surgery (not including anal procedures \\>3 months ago, e.g. haemorrhoid excision)\n7. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks\n8. Overt or planned pregnancy\n9. Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator\n10. Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator\n11. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)\n12. Previous enrolment in the present study\n13. Participation in another clinical study within the last 30 days that may interfere with the present study'}, 'identificationModule': {'nctId': 'NCT02709395', 'briefTitle': 'Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wellspect HealthCare'}, 'officialTitle': 'Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart', 'orgStudyIdInfo': {'id': 'NAV-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navina Smart', 'description': 'Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).', 'interventionNames': ['Device: Navina Smart']}], 'interventions': [{'name': 'Navina Smart', 'type': 'DEVICE', 'description': 'Transanal irrigation at the same frequency as subject used before enrollment.', 'armGroupLabels': ['Navina Smart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Neurologiska kliniken, Karolinska Universitetssjukhuset Solna', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Gastrointestinal Physiology Unit, University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wellspect HealthCare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}