To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the FaceNCT05957029

Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

A study testing NuEra Tight RF system in people with To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face, run by Lumenis Be Ltd. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face
What is being tested?: NuEra Tight RF system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 2 sitesUnited States
Study dates: 22 Jun 2023to 19 Jul 2023
Phase: Interventional
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy subjects of either gender, 18 years of age or older
Subject is able to read, understand and sign an informed consent form
Subject is willing to comply with all study procedures

Who cannot join

Subjects taking medicines that increase skin sensitivity to heat
Subjects taking medicines that change skin metabolism
Cancer or any pigmentary or vascular lesions in the planned treatment area
Subjects with Herpes simplex in the area to be treated
Pregnant women
Subjects wearing pacemakers and/or any other type of implanted electronics

Show all 17Show fewer

Subjects with any inflammatory skin conditions
Subjects with active cold sores, open lacerations, abrasions
Chronic or acute skin infections
Subjects with active local or systemic infections
Subjects with any disease in which an increase of skin temperature is contraindicated
Subjects wearing piercing in the area to be treated
Subjects have nerve insensitivity to heat in the area to be treated
Subjects have metal implants in the area to be treated, excluding dental implants
Subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile
Any condition where the study investigator determined that the subject is not adequate for this study
Subjects participating in other studies

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cosmedic Dermatology
Detroit, Michigan, 48230
Lewis Dermatology & Associates
New York, New York, 10021

Other trials in United States

About this study

The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.

Conditions: To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face
Being tested: NuEra Tight RF system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NuEra Tight RF systemDevice
monopolar radiofrequency device

Study groups in NCT05957029
Study group	Role	What they receive
Nuera Tight RF System	Experimental	Subjects will receive an RF treatment session on the periorbital area and cheeks with a frequency of 1 and 4 MHz. Each subject will be treated on one side of the face using a 10 mm capacitive electrode, and on the other side using a 20 mm capacitive electrode. The target temperature will be set at 42 C. Receives: Device: NuEra Tight RF system

What is being measured

The primary outcome is the main question the study is designed to answer.

tissue heating
To verify tissue heating throughout the treatment duration applied on the face. The temperature will be set at 42 C, the operator will move the electrode in a continuous motion until the skin temperature reached the target temperature, then the treatment will continue for another 12 minutes. the skin temperature will be measured using an infrared thermometer to verify tissue heating
Measured: 12 minutes
temperature stability
To verify temperature stability throughout the treatment duration applied on the face. the skin temperature will be measured using an infrared thermometer every 3 minutes to verify temperature stability
Measured: 12 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 202319 Jul 2023

First posted24 Jul 2023
Study start22 Jun 2023
Primary completion19 Jul 2023
Study completion19 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the FaceStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05957029
Sponsor's protocol ID: LUM-VBU-NUERA-23-02
Status last verified: Jun 2023
First submitted: 21 Jun 2023
Last updated: 24 Jul 2023
Results posted: No
Data monitoring committee: 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 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Thermal Outcome and Safety of Nuera Tight RF System
ClinicalTrials.gov ID: NCT05957029
Acronym / sponsor ID: LUM-VBU-NUERA-23-02
Conditions: To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Lumenis Be Ltd.Industry (pharma, biotech, devices)
Study start: 22 Jun 2023 (actual)
Primary completion: 19 Jul 2023 (actual)
Study completion: 19 Jul 2023 (actual)
First posted: 24 Jul 2023 (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 purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nuera Tight RF System	Experimental	Device: NuEra Tight RF systemSubjects will receive an RF treatment session on the periorbital area and cheeks with a frequency of 1 and 4 MHz. Each subject will be treated on one side of the face using a 10 mm capacitive electrode, and on the other side using a 20 mm capacitive electrode. The target temperature will be set at 42 C.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy subjects of either gender, 18 years of age or older
Subject is able to read, understand and sign an informed consent form
Subject is willing to comply with all study procedures

Key exclusion criteria (17 listed)

Subjects taking medicines that increase skin sensitivity to heat
Subjects taking medicines that change skin metabolism
Cancer or any pigmentary or vascular lesions in the planned treatment area
Subjects with Herpes simplex in the area to be treated
Pregnant women

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
NuEra Tight RF systemmonopolar radiofrequency device	Device	Nuera Tight RF System

Primary outcome

tissue heating
Time frame: 12 minutes
To verify tissue heating throughout the treatment duration applied on the face. The temperature will be set at 42 C, the operator will move the electrode in a continuous motion until the skin temperature reached the target temperature, then the treatment will continue for another 12 minutes. the skin temperature will be measured using an infrared thermometer to verify tissue heating
temperature stability
Time frame: 12 minutes
To verify temperature stability throughout the treatment duration applied on the face. the skin temperature will be measured using an infrared thermometer every 3 minutes to verify temperature stability

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 24 Jul 2023.
Individual participant dataSharing planned: No

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.

Amy Lewis, MD principal investigator

Lewis Dermatology & Associates

Shauna Diggs, MD principal investigator

Cosmedic Dermatology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 17 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

tissue heating (time frame: 12 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05957029.

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 24 Jul 2023.