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

Elective Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721405
• Other study ID #: NWCT20-SS-003
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Elective Surgical Procedures

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