Non-invasive Lipolysis on Human Thighs and Saddlebags

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    BTL Industries Ltd.
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Updated on 19 February 2024
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Summary

The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.

Description

This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for non-invasive lipolysis and fat reduction in the thigh and saddlebag area. This is a prospective, open-label, two-arm study; therefore the participants will be assigned to two study groups. Each participant will complete 4 treatment visits and 2 follow-up visits.

Details
Condition Adipose Tissue Reduction
Age 21years - 70years
Treatment BTL-899
Clinical Study IdentifierNCT04221646
SponsorBTL Industries Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Body Mass Index (BMI) of 20 to 35 kg/m2
Visible excess of adipose tissue at the treatment sites (ARM 1 - thigh area; ARM 2 - saddlebags area)
Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation
No procedure for fat reduction (including cellulite treatment) in the last six months
Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation
Age between 21 and 70 years

Exclusion Criteria

Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
Cardiovascular diseases
Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
Femoral or inguinal hernia
Disturbance of temperature or pain perception
Pulmonary insufficiency
Metal implants
Drug pumps
Malignant tumor
Hemorrhagic conditions
Septic conditions and empyema
Acute inflammations
Systemic or local infection such as osteomyelitis and tuberculosis
Contagious skin disease
Elevated body temperature
Pregnancy
Breastfeeding
Injured or otherwise impaired muscles
Scars, open lesions, and wounds at the treatment area
Basedow's disease
Previous liposuction in the treatment area in the last six months
Unstable weight within the last 6 months (change in weight 3%)
Previous body contouring or cellulite treatments in the thighs area in the last six months
Any other disease or condition at the investigator's discretion
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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