Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-02-21 @ 3:07 AM
Study NCT ID:
NCT02005692
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2013-11-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study to Assess the DynaSense System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'barrett.larson@leafhealthcare.com', 'phone': '650-701-3652', 'title': 'Barrett Larson, MD, Chief Medical Officer', 'organization': 'Leaf Healthcare, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Upon removal of the patient sensor (within 5 minutes of removal), the subject's skin was assessed for any ADEs.", 'description': "If an ADE was present upon sensor removal, the subject's skin was re-assessed approximately 1 hour later prior to hospital discharge when possible. If re-assessment was not possible prior to discharge, a follow-up telephone call was made to subjects to determine time to resolution.", 'eventGroups': [{'id': 'EG000', 'title': 'DynaSense Sensor', 'description': 'All subjects enrolled in the study.', 'otherNumAtRisk': 70, 'otherNumAffected': 2, 'seriousNumAtRisk': 70, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema (Skin Redness)', 'notes': 'Localized erythema (skin redness) following removal of patient sensor.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'notes': 'Localized itching in skin region where patient sensor was removed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Irritation/Discomfort', 'notes': 'Skin irritation and discomfort following removal of patient sensor.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Primary Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DynaSense Sensor', 'description': 'All subjects enrolled in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.', 'description': 'The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.', 'unitOfMeasure': 'percentage of subjects with ADEs', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Turn Protocol Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DynaSense Sensor', 'description': 'All subjects who successfully completed the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Subjects will be followed for the length of hospital stay which is expected to average 5 days.', 'description': 'The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.', 'unitOfMeasure': 'percentage turn compliance', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DynaSense Sensor', 'description': "All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.\n\nThe rate of compliance with prescribed turning protocols was measured using the DynaSense System."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Discharged earlier than anticipated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DynaSense Sensor', 'description': 'All subjects who successfully completed the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '97'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects who successfully completed the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-10', 'studyFirstSubmitDate': '2013-11-27', 'resultsFirstSubmitDate': '2014-07-19', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-19', 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Primary Endpoint', 'timeFrame': 'Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.', 'description': 'The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.'}, {'measure': 'Turn Protocol Compliance', 'timeFrame': 'Subjects will be followed for the length of hospital stay which is expected to average 5 days.', 'description': 'The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pressure ulcers', 'bed sores', 'patient turn protocol', 'patient movement', 'patient monitoring'], 'conditions': ['Pressure Ulcers']}, 'descriptionModule': {'briefSummary': "The study is designed to test the DynaSense system, which is a patient movement and orientation monitoring system. The study is intended to determine that:\n\n* the DynaSense system identifies patients that are not turning adequately on their own and therefore require caregiver-assisted turns.\n* the DynaSense system identifies patients that are turning adequately on their own and therefore do not require a caregiver-assisted turn.\n* the DynaSense system helps ensure compliance with an institution's established patient turning protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male or female 18 to 110 years of age;\n* Inpatient currently on the unit and expected to remain for at least 12 hours;\n* Able and willing to comply with the study procedures;\n* Subject (or his/her agent) is able to read, understand, and provide Informed Consent in the English language.\n\nExclusion Criteria:\n\n* Subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding.\n\n 1. Any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; OR\n 2. Be postmenopausal for at least 2 years, OR\n 3. have had a bilateral tubal ligations, OR\n 4. have had a bilateral oophorectomy, OR\n 5. have had a hysterectomy.\n* Subjects with a known tape allergy or sensitivity to EKG leads or similar types of adhesives used in common medical products.\n* Subjects who cannot have the patient sensor applied on the surface of the patient's anterior torso.\n* Subjects who have a pacemaker or implantable cardiovascular-defibrillator (ICD).\n* Subjects with dementia, Alzheimer's disease or other mental disabilities and incapacitation that would prevent the subject from providing written informed consent. If the subject is unable to provide informed consent due to mental incapacity, then the subject's Durable Power of Attorney may provide informed consent and sign the informed consent on behalf of the subject.\n* Subjects who refuse to have an area of hair on their chest be clipped or shaved, if needed for patient sensor adhesion.\n* Subjects, who in the opinion of the Principal Investigator, are at increased risk by participating in the clinical study.\n* Subjects who have participated in another clinical study within the past 30 days or are currently participating in another clinical study at the time of screening."}, 'identificationModule': {'nctId': 'NCT02005692', 'briefTitle': 'A Pilot Study to Assess the DynaSense System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Leaf Healthcare, Inc.'}, 'officialTitle': 'A Pilot Study to Assess the DynaSense System', 'orgStudyIdInfo': {'id': 'CM-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DynaSense sensor', 'interventionNames': ['Device: DynaSense sensor']}], 'interventions': [{'name': 'DynaSense sensor', 'type': 'DEVICE', 'armGroupLabels': ['DynaSense sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Hospital', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Michelle Pezzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'El Camino Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leaf Healthcare, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centauri Medical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}