Elective Surgical Procedures
Conditions
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
Interventions
DEVICEObservational Study: No intervention
Observational Study: No intervention
Sponsors
Nanowear Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject assessment of comfort and compliance | 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
| Measure | Time frame | Description |
|---|---|---|
| Investigator assessment of device usability and satisfaction | through study completion, an average of 1 year | 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. 3\. Investigator assessment of satisfaction will be filled out by PI using a 5-points Likert scale, as follows: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Extremely disappointed. |
Countries
United States
Outcome results
None listed