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

NCT05388617 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-11-29

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Cynosure, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Civiok · Director of Clinical Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2022-08-24
Completion
2022-08-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388617 on ClinicalTrials.gov