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

• Sponsor: Nanowear Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04721405
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 15.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	Phase
Elective Surgical Procedures	Device: Observational Study: No intervention

Study Design

• Study Type: Observational
• Anticipated 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: Sep 14, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Outcome Measures

Primary Outcome Measures

1. Subject assessment of comfort and compliance [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Zucker School of Medicine, Hofstra University	New York	New York	United States	10019

Sponsors and Collaborators

• Nanowear Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nanowear Inc.
• ClinicalTrials.gov Identifier: NCT04721405
• Other Study ID Numbers: NWCT20-SS-003
• First Posted: Jan 22, 2021
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jan 22, 2021