Safety and Efficacy of Electronic Stimulation for Circumferential Reduction and Muscle Toning

NCT ID: NCT06152900

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2023-11-20

Brief Summary

Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Each subject will receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2, 30- and 90-days post treatment. Measurement outcomes will be compared to baseline.

Conditions

Fat Necrosis; Muscle Stimulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

All subjects enrolled in the study will be placed into the treatment arm of the study, to be treated by the Accufit device.

Group Type: EXPERIMENTAL

Accufit

Intervention Type: DEVICE

Magnet-based and Direct muscle stimulation devices are commonly used to generate current flow through the muscles in order to activate the muscle. The Accufit Electrical Muscle Stimulation device is an FDA cleared device having a two-channel stimulator that provides up to 8 electrodes with waveforms of interferential and biphasic for muscle stimulation. The Accufit system is indicated for relaxation of muscles, muscle re-education, reduction of pain and increased local blood circulation.

Muscle stimulation technology has been around for many decades and has been shown to be safe and effective for a variety of clinical applications. The foundational basis for the technology revolves around electrical current flowing through the muscle can be used to activate the muscle.

Interventions

Accufit

Magnet-based and Direct muscle stimulation devices are commonly used to generate current flow through the muscles in order to activate the muscle. The Accufit Electrical Muscle Stimulation device is an FDA cleared device having a two-channel stimulator that provides up to 8 electrodes with waveforms of interferential and biphasic for muscle stimulation. The Accufit system is indicated for relaxation of muscles, muscle re-education, reduction of pain and increased local blood circulation.

Muscle stimulation technology has been around for many decades and has been shown to be safe and effective for a variety of clinical applications. The foundational basis for the technology revolves around electrical current flowing through the muscle can be used to activate the muscle.

Intervention Type: DEVICE

Other Intervention Names

ME Sys*STIM 240

Eligibility Criteria

Inclusion Criteria

1. Able to read, understand and voluntarily provide written informed consent.

2. Healthy male or female, ≥ 18 years to 65 years of age seeking treatment for improved muscle strength and muscle toning in their core and extremities.

3. Subject is determined to be physically fit and agrees to not making any major changes in their diet or lifestyle during the study.

4. Able and willing to comply with the treatment/follow-up schedule and requirements.

5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study as well as have a negative Urine Pregnancy test at baseline.

Exclusion Criteria

1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.

2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.

3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the study.

4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.

5. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or premalignant pigmented lesions.

6. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone in the treatment area.

7. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections.

8. Poor skin quality (severe laxity).

9. Abdominal wall, muscular abnormality or hernia on physical examination.

10. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.

11. Subjects unwilling or unable to adhere to all study requirements for treatment and follow-up.

12. Investigator may exclude any subject at any time at his/her discretion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LUTRONIC Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lutronic US Headquarters

Billerica, Massachusetts, United States

Union Square Dermatology

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AFL19006

Identifier Type: -

Identifier Source: org_study_id