NCT05388617

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

Prospective Clinical Study To Assess The Safety And Efficacy Of A Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 30 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups, Group A and Group B. Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for all visits as outlined in "Schedule of Visits and Procedures - Group A". Subjects will enroll in Group B for training and experience purposes only and will follow the visit schedule as outlined in "Schedule of Visits and Procedures - Group B".

Conditions

• Muscle Stimulation
• Abdominal Fat

Interventions

Type	Name	Description
DEVICE	Brera	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.

Timeline

• Start date: 2022-05-10
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2022-05-24
• Last updated: 2023-11-29
• Results posted: 2023-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study