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Device

Abdominal Toning and Reduction of Subcutaneous Fat 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 7 months
Awards & highlights

Summary

This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in fat and muscle thickness in the abdominal area measured via ultrasound.
Secondary outcome measures
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
Patient's satisfaction with study treatment measured via questionnaires

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Abdominal Toning and Reduction of Subcutaneous FatExperimental Treatment1 Intervention
The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator of BTL-703 will be applied over the umbilicus. The active group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with heating of the subcutaneous fat.
Group II: Sham controlPlacebo Group1 Intervention
The treatment administration phase will also consist of three (3) treatments, delivered once a week. The sham group will receive a treatment with the intensities of the magnetic field and radiofrequency energy set to 5% of the maximum device output.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BTL-899
2022
N/A
~440

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Who is running the clinical trial?

BTL Industries Ltd.Lead Sponsor
51 Previous Clinical Trials
1,735 Total Patients Enrolled
~11 spots leftby Sep 2025
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