Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01617512
Status:
COMPLETED
Last Update Posted:
2014-04-11
First Post:
2011-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Accelerometer Signals to Measure Daily Activities (SASMDA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-10', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data.', 'timeFrame': '6 months', 'description': 'Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data'}], 'secondaryOutcomes': [{'measure': 'Score of satisfaction with the use of the medical device, assessed by the patients', 'timeFrame': '6 months', 'description': 'Score between 0 and 10, takes into account the feasibility of the proposed approach and the patient felt the importance of this feasibility.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Urinary Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* man\n* patients fitted with artificial urinary sphincter\n* patients affiliated to social security or similar regime\n\nExclusion Criteria:\n\n* patient do not speak french\n* patient unable to express his consent\n* patient hospitalize without consent\n* patient under legal protection\n* patient deprived of liberty'}, 'identificationModule': {'nctId': 'NCT01617512', 'briefTitle': 'Study Accelerometer Signals to Measure Daily Activities (SASMDA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Study Accelerometer Signals to Measure Daily Activities: a Pilot Study', 'orgStudyIdInfo': {'id': 'DCIC 1116'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LIS302DL accelerometer', 'type': 'DEVICE', 'description': 'Recording for 24 hours accelerations related to daily physical activity of the patient.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Alexandre Moreau-gaudry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdministrateurCIC', 'class': 'OTHER'}, 'collaborators': [{'name': 'TIMC-IMAG', 'class': 'OTHER'}, {'name': 'Laboratory TIMA', 'class': 'UNKNOWN'}, {'name': 'Clinical Investigation Centre for Innovative Technology Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'AdministrateurCIC', 'investigatorAffiliation': 'University Hospital, Grenoble'}}}}