Non-invasive Lipolysis on Human Thighs and Saddlebags

NCT04221646 | Completed

• 1 other identifier: BTL-899THI
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.

Conditions

Adipose Tissue Reduction

Outcome Measures

Primary Outcomes (3)

• Changes in Fat Thickness Measured via Ultrasound

  To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on thighs and saddlebags. The fat thickness changes will be measured by means of ultrasound.

  6 months

• Participants' Satisfaction Measured Via Questionnaires

  Evaluation of the participants' satisfaction with the therapy via Therapy Satisfaction Questionnaires. Global Aesthetic Improvement Scale (Quality of Life questionnaire) will be used where score "3" means "very much improved" and "-3" is "very much worse".

  6 months

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

  The outcome will further be measured through the occurrence of adverse events or lack thereof. On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment.

  6 months

Study Arms (2)

Thighs circumference reduction

EXPERIMENTAL

The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied simultaneously.

Device: BTL-899

Saddlebags fat thickness reduction

EXPERIMENTAL

The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied consecutively too.

Device: BTL-899

Interventions

BTL-899 DEVICE

Treatment with study device.

Saddlebags fat thickness reduction; Thighs circumference reduction

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 sites (ARM 1 - thigh area; ARM 2 - saddlebags 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.
• No procedure for 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.
• Age between 21 and 70 years.

You may not qualify if:

• Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
• Cardiovascular diseases
• Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
• Femoral or inguinal hernia
• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Aesthe Clinic

Sofia, 1700, Bulgaria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 9, 2020
• Study Start: January 28, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 13, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)