Non-invasive Lipolysis and Improvement of Muscle Tone in Inner Thighs

NCT04596228 | Completed FDA Device

• 1 other identifier: BTL-899_200
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the clinical efficacy and safety of the BTL-899 device for changes in subcutaneous fat tissue and muscle tissue of inner thighs. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device

Conditions

Fat Disorder

Outcome Measures

Primary Outcomes (3)

• The evaluation of structural changes of subcutaneous tissues of the inner thighs

  The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues.

  4 months

• The evaluation of structural changes of subcutaneous tissues of the inner thighs

  The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through evaluation of tissue composition and morphology.

  4 months

• The evaluation of change in adipose layer thickness

  The evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on thigh circumference measurements.

  4 months

Secondary Outcomes (2)

• Patient's satisfaction with study treatment measured via questionnaires

  4 months

• Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire

  4 months

Study Arms (1)

Experimental

EXPERIMENTAL

Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device

Device: BTL-899

Interventions

BTL-899 DEVICE

Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.

Experimental

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pinchable fat layer at the thigh region
• 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 (1)

Plastic Surgical Associates

Fort Collins, Colorado, 80525, United States

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

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 8, 2020
• First Posted: October 22, 2020
• Study Start: October 15, 2020
• Primary Completion: May 10, 2021
• Study Completion: July 6, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)