Effect of BTL-899 Device for Non-invasive Lipolysis on Human Flanks

NCT05260164 | Completed

• 1 other identifier: BTL-899_CTBG200
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the clinical safety and the performance of the BTL-899 device (with its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as "love handles"). The study has a single-arm, open-label, interventional design. The subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits. Both flanks will be treated simultaneously for 30 minutes per session. The flanks' fat thickness reduction will be documented by ultrasound. At the baseline visits health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. The treatment administration phase consists of four (4) treatment visits, delivered 5 - 10 days apart. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-899 device. 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.

Conditions

Fat Burn

Outcome Measures

Primary Outcomes (1)

• Change of fat thickness in the flanks area evaluated by ultrasound

  To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on human flanks

  5 months

Secondary Outcomes (2)

• Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire

  5 months

• Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires

  5 months

Study Arms (1)

HIFEM+RF

EXPERIMENTAL

The subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits. Both flanks will be treated simultaneously with the BTL-899 device for 30 minutes per session.

Device: HIFEM+RF

Interventions

HIFEM+RF DEVICE

Combination of High-Intensity Focused Electromagnetic Field (HIFEM) and a high radio frequency (RF) field.

HIFEM+RF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) of 20 to 35 kg/m2.
• Visible excess of adipose tissue confirmed with pinch test at the flanks ("love handles") 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.
• Successful initial determination of the flanks' fat thickness by means of ultrasound.
• No procedure for fat reduction at the treated area 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 18 and 70 years.

You may not qualify if:

• Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
• Metal implants
• Drug pumps
• Malignant tumor
• Pulmonary insufficiency
• Injured or otherwise impaired muscles in the treatment area
• Cardiovascular diseases
• Disturbance of temperature or pain perception
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Pregnancy, postpartum period, nursing

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Outpatient Practice for Specialized Medical Care - Individual practice for specialized medical dermatology care Mariya Genova MD

Plovdiv, Bulgaria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: March 11, 2022
• Primary Completion: November 30, 2022
• Study Completion: January 30, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)