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

NCT04643275 | Completed

• 1 other identifier: BTL-899A
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.

Conditions

Fat Burn

Outcome Measures

Primary Outcomes (1)

• Statistically significant reduction of fat thickness in the upper arms evaluated by photographs

  To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on upper arms. The primary efficacy outcome measure is a minimum 75% of the subjects' pre-treatment and 3-months follow-up images to be correctly identified by at least two of three independent blinded evaluators.

  5 months

Secondary Outcomes (2)

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

  7 months

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

  5 months

Study Arms (1)

Non-invasive lipolysis of the upper arms

EXPERIMENTAL

The treatment administration phase consists of four (4) treatment visits, delivered 5- 10 - days apart. Each therapy session will last 30 minutes. Follow-ups visits at 1 month and 3 months after the final treatment will be held.

Device: BTL-899

Interventions

BTL-899 DEVICE

Treatment with study device.

Non-invasive lipolysis of the upper arms

Eligibility Criteria

• Age: 21 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 at the treatment site
• 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 fat reduction in the 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 the study participation.

You may not qualify if:

• Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
• Cardiovascular diseases
• Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
• Disturbance of temperature or pain perception
• Pulmonary insufficiency
• Metal implants
• Drug pumps
• Malignant tumor
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Pregnancy

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Dr Denkova Dermatology

Sofia, 1700, 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: November 3, 2020
• First Posted: November 25, 2020
• Study Start: October 15, 2020
• Primary Completion: August 2, 2021
• Study Completion: September 2, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)