Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

NCT ID: NCT04000945

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2019-12-31

Brief Summary

The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits

Detailed Description

This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.

Conditions

Improvement of Abdomen Appearance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BTL-899 Therapy Arm

Group Type: EXPERIMENTAL

BTL-899

Intervention Type: DEVICE

Treatment with BTL-899 device, 3 therapies

Sham Arm

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Sham treatment with BTL-899 device, 3 visits

Interventions

BTL-899

Treatment with BTL-899 device, 3 therapies

Intervention Type: DEVICE

Sham

Sham treatment with BTL-899 device, 3 visits

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age > 21 years
• Voluntarily signed informed consent form
• BMI ≤ 35 kg/m2
• Women of child-bearing potential are required to use birth control measures during the whole duration of the study
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
• Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria

• Cardiac pacemakers
• Cardiovascular diseases
• Implanted defibrillators, implanted neurostimulators
• Electronic implants
• 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
• Contageous skin disease
• Elevated body temperature
• Pregnancy
• Breastfeeding
• Injured or otherwise impaired muscles
• Scars, open lesions and wounds at the treatment area
• Basedow's disease
• Previous liposuction in the treatment area in the last six months
• Abdominal wall diastasis
• Unstable weight within the last 6 months
• Previous body contouring treatments in the abdomen area in the last three months

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BTL Industries Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr-Denkova Dermatology

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

BTL-899S

Identifier Type: -

Identifier Source: org_study_id