Elective Surgical ProceduresNCT04721405
Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
An observational study of Elective Surgical Procedures, run by Nanowear Inc. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgical Procedures
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female over the age of 18 years, healthy adults scheduled to undergo BodyTite and/or FaceTite procedures.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Zucker School of Medicine, Hofstra University
New York, New York, 10019
About this study
The objective of this study is to evaluate an experience of post-operative monitoring using the Nanowear wearable multiple sensor vest in plastic surgery
- Conditions
- Elective Surgical Procedures
- Being tested
- Observational Study: No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study: No interventionDevice
Observational Study: No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject assessment of comfort and compliance
- 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.
Measured: 7 days
Secondary outcomes (1)
Investigator assessment of device usability and satisfaction
- 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.
- 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start14 Sep 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanowear Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721405
- Sponsor's protocol ID
- NWCT20-SS-003
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
- ClinicalTrials.gov ID
- NCT04721405
- Acronym / sponsor ID
- NWCT20-SS-003
- Conditions
- Elective Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nanowear Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female over the age of 18 years, healthy adults scheduled to undergo BodyTite and/or FaceTite procedures.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study: No interventionObservational Study: No intervention | Device | – |
Primary outcome
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.
1 secondary outcome
Investigator assessment of device usability and satisfaction
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Surgical Procedures, run by Nanowear Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject assessment of comfort and compliance (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.