Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04721405
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2021-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject assessment of comfort and compliance', 'timeFrame': '7 days', 'description': "1\\. Subject assessment of comfort and compliance will be filled out by subjects using a 6-points Usability Survey, as follows:\n\n* Overall Size of the device - 0 - Being the largest device 5 -Being the smallest.\n* Secrecy - If patient's are uneasy of people knowing they are wearing a medical device. 0 - Not able to hide 5 - Discrete\n* Adaptable to size - Can devices be used on all size patients, extreme scales. 0- Not adjustable 5- Can fit all sizes\n* Device Material - Is the material comfortable to wear. 0 - Uncomfortable 5 - Comfortable\n* Active Wear - Can patient's wear the device while exercising. 0- Not at all 5 - Can exercise without interference."}], 'secondaryOutcomes': [{'measure': 'Investigator assessment of device usability and satisfaction', 'timeFrame': 'through study completion, an average of 1 year', 'description': '2\\. Investigator assessment of device usability will be filled out by PI using a 4-points Likert scale, as follows: 3 = Extremely useful in post op care; 2 = Useful in post op care; 1 = Somewhat useful in post op care; 0 = Useless in post op care.\n\n3\\. Investigator assessment of satisfaction will be filled out by PI using a 5-points Likert scale, as follows:\n\n+2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Extremely disappointed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Elective Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate an experience of post-operative monitoring using the Nanowear wearable multiple sensor vest in plastic surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female over the age of 18 years, healthy adults scheduled to undergo BodyTite and/or FaceTite procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent to participate in the study.\n* Female and male subjects, at least 18 years of age at the time of enrolment\n* The patient is scheduled to undergo BodyTite and/or FaceTite procedures.\n* The patients should be willing to comply with the study procedure and schedule.\n\nExclusion Criteria:\n\n* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.\n* Pregnancy and nursing.\n* Subject unwilling or unable to comply with wearing the Nanowear System 12 hours daily for at least 48 hours Up to 7 days\n* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient"}, 'identificationModule': {'nctId': 'NCT04721405', 'briefTitle': 'Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanowear Inc.'}, 'officialTitle': 'Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest', 'orgStudyIdInfo': {'id': 'NWCT20-SS-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational Study: No intervention', 'type': 'DEVICE', 'description': 'Observational Study: No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Shusterman', 'role': 'CONTACT', 'email': 'maria.shusterman@inmodemd.com', 'phone': '416-458-9001'}, {'name': 'Daniel Delvecchio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zucker School of Medicine, Hofstra University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Maria Shusterman', 'role': 'CONTACT', 'email': 'maria.shusterman@inmodemd.com', 'phone': '4164589001'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanowear Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}