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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04721405
Other study ID # NWCT20-SS-003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 14, 2020
Est. completion date December 31, 2023

Study information

Verified date November 2023
Source Nanowear Inc.
Contact Maria Shusterman
Phone 4164589001
Email maria.shusterman@inmodemd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Observational Study: No intervention
Observational Study: No intervention

Locations

Country Name City State
United States Zucker School of Medicine, Hofstra University New York New York

Sponsors (1)

Lead Sponsor Collaborator
Nanowear Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Investigator assessment of device usability and satisfaction 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
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