BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen (NCT04621019) | Clinical Trial Compass
CompletedNot Applicable
BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen
Bulgaria70 participantsStarted 2021-11-11
Plain-language summary
This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-1 applicator for non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Follow-ups visits at 1 month and 3 months after the final treatment will be held.
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* Healthy male or female subjects over 21 years of age seeking treatment for abdominal circumference reduction
* Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
* Presence of clearly visible fat deposits in the abdominal area as deemed appropriate by the Investigator (e.g. by pinch test or ultrasound fat thickness measurement)
* 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 abdominal 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.
* Willingness to comply with study instructions and to return to the clinic for required visits.
Exclusion Criteria:
* Bacterial or viral infection, acute inflammations
* Impaired immune system
* Isotretinoin use in the past 12 months
* Skin related autoimmune diseases
* Radiation therapy and/or chemotherapy
* Poor healing and unhealed wounds in the treatment area
* Metal implants
* Permanent implant in the treated area
* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
* Current or history of skin cancer, or curr…
What they're measuring
1
Statistically significant reduction of abdominal fat thickness determined with ultrasound