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

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ClinicalTrials.gov Identifier: NCT04721405
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Nanowear Inc.

Study Description
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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

Condition or disease Intervention/treatment
Elective Surgical Procedures Device: Observational Study: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Groups and Cohorts
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Intervention Details:
  • Device: Observational Study: No intervention
    Observational Study: No intervention

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721405


Contacts
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Contact: Maria Shusterman 4164589001 maria.shusterman@inmodemd.com

Locations
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United States, New York
Zucker School of Medicine, Hofstra University Recruiting
New York, New York, United States, 10019
Contact: Maria Shusterman    416-458-9001    maria.shusterman@inmodemd.com   
Principal Investigator: Daniel Delvecchio, MD         
Sponsors and Collaborators
Nanowear Inc.
More Information
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Responsible Party: Nanowear Inc.
ClinicalTrials.gov Identifier: NCT04721405    
Other Study ID Numbers: NWCT20-SS-003
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes