Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat

NCT05388617 | Terminated Results FDA Device

• 1 other identifier: MED4-PL01-2022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The intended use of the device in this study to assess the safety and efficacy of the adhesive electrodes for muscle stimulation and the treatment of abdominal fat on the abdomen and/or flanks.

Conditions

Muscle Stimulation; Abdominal Fat

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Satisfied

  The number of subjects satisfied with their treatment will be reported.

  30 days follow up.

Study Arms (2)

Group A

EXPERIMENTAL

Subjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments.

Device: Brera

Group B

EXPERIMENTAL

Subjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group.

Device: Brera

Interventions

Brera DEVICE

The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A healthy male or female 18 years of age or older.
• Agrees to be treated with the Brera/Med 400 device.
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document.

You may not qualify if:

• Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
• Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
• Has injured (such as a cut, wound) or infected skin, or has presence of evident pathologies such as melanomas or other tumors of the skin, dermatitis, eczema, psoriasis, etc. in the area to be treated.
• Is on local, oral, or systemic anesthetic agents.
• Has nerve insensitivity to heat in the treatment area.
• Has received an organ transplant.
• Has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment.
• Has an embedded pacemaker or implantable cardioverter defibrillator (ICD), the client's cardiologist must be consulted prior to treatment.
• NOTE: This device has not been tested on patients implanted with electronic devices that receive or emit signals, such as: Pacemakers, Implantable Cardiac Defibrillators (ICD), or Cardiac Resynchronization Therapy (CRT) devices.
• If the neutral pad would need to be placed on a subject that has a metal plate, rod, or any metal implant that could conduct heat.
• Has an allergy to adhesives, such as glues on medical tape, they should be alerted that a rash may occur on the applicator and neutral pad site, and an over-the-counter solution may be used to treat the area.
• Has an unhealthy expectation of the results - this is not plastic surgery and all subjects should be fully informed of the treatment's expected results.
• Has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated - this treatment will be ineffective.
• Has used Accutane (Isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
• Is currently taking anticoagulants.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Cynosure, Inc.

Westford, Massachusetts, 01886, United States

Location

Related Publications (1)

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

  PMID: 31896400 RESULT

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

9782564200

Study Officials

• Jennifer Civiok

  Director of Clinical Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for up to 8 treatment visits spaced approximately 1 week apart. Subjects will enroll in Group B for training and experience purposes only and will be able to attend up to 8 treatments spaced at least 3 days apart.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: May 10, 2022
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)