Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nanowear Inc.
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Subject assessment of comfort and compliance
Study Overview
Brief Summary
The objective of this study is to evaluate an experience of post-operative monitoring using the Nanowear wearable multiple sensor vest in plastic surgery
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent to participate in the study.
- •Female and male subjects, at least 18 years of age at the time of enrolment
- •The patient is scheduled to undergo BodyTite and/or FaceTite procedures.
- •The patients should be willing to comply with the study procedure and schedule.
Exclusion Criteria
- •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- •Pregnancy and nursing.
- •Subject unwilling or unable to comply with wearing the Nanowear System 12 hours daily for at least 48 hours Up to 7 days
- •As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
Outcomes
Primary Outcomes
Subject assessment of comfort and compliance
Time Frame: 7 days
1\. Subject assessment of comfort and compliance will be filled out by subjects using a 6-points Usability Survey, as follows: * Overall Size of the device - 0 - Being the largest device 5 -Being the smallest. * Secrecy - If patient's are uneasy of people knowing they are wearing a medical device. 0 - Not able to hide 5 - Discrete * Adaptable to size - Can devices be used on all size patients, extreme scales. 0- Not adjustable 5- Can fit all sizes * Device Material - Is the material comfortable to wear. 0 - Uncomfortable 5 - Comfortable * Active Wear - Can patient's wear the device while exercising. 0- Not at all 5 - Can exercise without interference.
Secondary Outcomes
- Investigator assessment of device usability and satisfaction(through study completion, an average of 1 year)