NCT04296201

Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A total of at least 15 and up to 17 healthy subjects at a single site, aged 25-45 years old, who wish to receive a lifting effect and improved muscle definition, will be included in the study. The procedure will include treatments with the Legend Pro™ DMA™ technology. Photos will be obtained at pre-defined time points throughout the study.

Detailed description

Single center, prospective, open Label with Before \& After Study Design. This study is designed to evaluate the immediate efficacy and safety of Legend Pro™'s DMA™ muscle stimulation technology. Treatment areas will include the face, buttocks, or abdominal region. Each subject will receive 1 treatment with no follow-up visits required. Interim assessment will be held after half of the study population has received treatment. The study population will be divided into three arms as follows: * 5 female subjects will receive treatment in the face area * 5 female subjects will receive treatment in the buttocks area * 5 male subjects will receive treatment in the abdominal region

Conditions

• Skin Laxity
• Muscle Contracture

Interventions

Type	Name	Description
DEVICE	DMA treatment	Each arm will receive the DMA treatment in a specific area on the body to observe immediate effect.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-02-15
• Completion: 2021-02-15
• First posted: 2020-03-05
• Last updated: 2021-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study