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Procedure

BTL-899 for Fat Burning

N/A
Waitlist Available
Research Sponsored by BTL Industries Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. The study is a prospective single-center single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment and Group B which receives sham treatment and will serve as a control to verify the treatment outcomes. Subjects will be required to complete only one (1) treatment visit and three (3) follow-up visits (at 8 hours, 24 hours and 7 days post treatment). All of the study subjects will receive the treatment (either active or sham) with the subject device. At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies from the treated abdominal area will be taken to examine the changes related to caspase-3 activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Increased caspase-3 activity
Secondary outcome measures
Safety assessment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Histological evaluation of BTL-899 device´s effect on fat tissueExperimental Treatment1 Intervention
This group will be treated with 100% of the treatment parameter settings
Group II: Sham treatmentPlacebo Group1 Intervention
This group will be treated with 5% of the treatment parameter settings
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BTL-899
2017
N/A
~390

Find a Location

Who is running the clinical trial?

BTL Industries Ltd.Lead Sponsor
51 Previous Clinical Trials
1,795 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New Jersey
New York
How old are they?
18 - 65
What site did they apply to?
Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Apr 2025