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OpenTrials
Completed

NCT Number: NCT04721405

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

The objective of this study is to evaluate an experience of post-operative monitoring using the Nanowear wearable multiple sensor vest in plastic surgery

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Key information

Conditions

Elective Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zucker School of Medicine, Hofstra University

New York, 10019, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Study: No intervention

Device

Observational Study: No intervention

Primary outcomes

  1. Subject assessment of comfort and compliance

    Time frame: 7 days

    • 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

  1. Investigator assessment of device usability and satisfaction

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

    • 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.
    • 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.

Sponsors and collaborators

Lead sponsor

Nanowear Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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