Fat Reduction and Muscle Toning of Thighs

NCT04599257 | Completed FDA Device

• 1 other identifier: BTL-703_300
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 4

Brief Summary

This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.

Conditions

Fat Burn

Keywords

muscle strengthening; muscle tone; fat reduction

Outcome Measures

Primary Outcomes (1)

• Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging

  The primary objective of the study is to determine the effectiveness of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for change in the adipose layer thickness between pre-treatment and post-treatment based on MRI imaging. The changes will be considered statistically significant where p-value \<0.05.

  7 months

Secondary Outcomes (2)

• Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire

  7 months

• Assess safety profile by recording of adverse events

  7 months

Study Arms (1)

Hip and thigh circumference changes

EXPERIMENTAL

The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit, MRI imaging will be performed; the subject's weight and hip and thigh circumference will be recorded. Photos of the treated area will be taken. The treatment administration phase will consist of four (4) treatments, delivered once a week. The applicator of the device will be applied over the treatment area. The device will induce visible muscle contractions along with heating of the subcutaneous fat. At the last therapy visit, the subject's weight and hip and thigh circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.

Device: BTL-899

Interventions

BTL-899 DEVICE

The device applicator combines high-intensity focused electromagnetic procedure and radiofrequency energy to induce visible muscle contractions along with heating of the subcutaneous fat.

Hip and thigh circumference changes

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 21 years
• Voluntarily signed an informed consent form
• BMI ≤ 35 kg/m2
• Women of child-bearing potential are required to use birth control measures during the whole duration of the study
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
• Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

You may not qualify if:

• Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
• Metal implants
• Drug pumps
• Malignant tumor
• Pulmonary insufficiency
• Injured or otherwise impaired muscles
• Cardiovascular diseases
• Disturbance of temperature or pain perception
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Pregnancy, postpartum period, nursing, and menstruation

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (4)

Brian M. Kinney M.D., Inc

Beverly Hills, California, 90212, United States

Location

Art of Skin MD

Solana Beach, California, 92075, United States

Location

Yael Halaas, M.D., F.A.C.S.

New York, New York, 10022, United States

Location

Center For SmartLipo & Plastic Surgery

Langhorne, Pennsylvania, 19047, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 22, 2020
• Study Start: September 15, 2020
• Primary Completion: June 24, 2021
• Study Completion: January 20, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)