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 range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Statistically significant reduction of abdominal fat thickness determined with ultrasound