Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

NCT05957029 | Completed FDA Device

• 1 other identifier: LUM-VBU-NUERA-23-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 minutes

Study Arms (1)

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.

Device: NuEra Tight RF system

Interventions

NuEra Tight RF system DEVICE

monopolar radiofrequency device

Nuera Tight RF System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (2)

Cosmedic Dermatology

Detroit, Michigan, 48230, United States

Location

Lewis Dermatology & Associates

New York, New York, 10021, United States

Location

Study Officials

• Amy Lewis, MD

  Lewis Dermatology & Associates

  PRINCIPAL INVESTIGATOR

• Shauna Diggs, MD

  Cosmedic Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 24, 2023
• Study Start: June 22, 2023
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)