Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest

Nanowear Inc.44 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Elective Surgical Procedures

Interventions

Observational Study: No interventionDEVICE

Observational Study: No intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Zucker School of Medicine, Hofstra University

New York, New York, United States

Outcomes

Primary Outcomes

Subject assessment of comfort and compliance

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.

Time frame: 7 days

Secondary Outcomes

Investigator assessment of device usability and satisfaction

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.

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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