NCT06152900

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

Clinical Evaluation of the Safety and Efficacy of Electronic Stimulation for Non-Invasive Circumferential Reduction and Muscle Toning

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-10-05
• Primary completion: 2022-11-20
• Completion: 2023-11-20
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study