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

November 7, 2023 updated by: Nanowear Inc.
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Recruiting
        • Zucker School of Medicine, Hofstra University
        • Contact:
        • Principal Investigator:
          • Daniel Delvecchio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject assessment of comfort and compliance
Time Frame: 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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator assessment of device usability and satisfaction
Time Frame: 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanowear Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NWCT20-SS-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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