Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
- Conditions
- Elective Surgical Procedures
- Registration Number
- NCT04721405
- Lead Sponsor
- Nanowear Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Zucker School of Medicine, Hofstra University
🇺🇸New York, New York, United States