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

NCT04721405 | Completed FDA Device

• 1 other identifier: NWCT20-SS-003
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Elective Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (1)

• Investigator assessment of device usability and satisfaction

  through study completion, an average of 1 year

Interventions

Observational Study: No intervention DEVICE

Observational Study: No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female over the age of 18 years, healthy adults scheduled to undergo BodyTite and/or FaceTite procedures.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanowear Inc.: lead

Study Sites (1)

Zucker School of Medicine, Hofstra University

New York, New York, 10019, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: September 14, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)