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

NCT04000945 | Unknown

• 1 other identifier: BTL-899S
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Improvement of Abdomen Appearance

Outcome Measures

Primary Outcomes (2)

• Efficacy of the BTL-899 treatment for change in abdominal circumference

  Comparison of change in abdominal circumference at the final follow-up visit between two study groups.

  4 months

• Occurrence of adverse events

  The occurrence of adverse events will be followed throughout the whole study.

  7 months

Secondary Outcomes (5)

• Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators

  4 months

• Efficacy of the BTL-899 treatment for change in abdominal circumference

  4 months

• Efficacy of the BTL-899 treatment for abdominal fat reduction

  4 months

• Subject's satisfaction with study treatment

  4 months

• Therapy comfort during the study treatment.

  1 month

Study Arms (2)

BTL-899 Therapy Arm

EXPERIMENTAL

Device: BTL-899

Sham Arm

SHAM COMPARATOR

Device: Sham

Interventions

BTL-899 DEVICE

Treatment with BTL-899 device, 3 therapies

BTL-899 Therapy Arm

Sham DEVICE

Sham treatment with BTL-899 device, 3 visits

Sham Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: December 3, 2018
• Primary Completion: December 3, 2019
• Study Completion: December 31, 2019
• Last Updated: June 27, 2019

Record last verified: 2019-06

Locations

BU (1)