NCT04596241

Brief Summary

This study will evaluate the clinical efficacy and safety of the BTL-899 device for changes in subcutaneous fat tissue and muscle tissue of arms. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

October 8, 2020

Last Update Submit

August 26, 2022

Conditions

Fat Disorder

Outcome Measures

Primary Outcomes (3)

  • The evaluation of structural changes of subcutaneous tissues of the of the upper arms

    The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues

    4 months

  • The evaluation of structural changes of subcutaneous tissues of the of the upper arms

    The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through evaluation of tissue composition and morphology.

    4 months

  • The evaluation of change in adipose layer thickness

    The evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on arm circumference measurements.

    4 months

Secondary Outcomes (2)

  • Patient's satisfaction with study treatment measured via questionnaires

    4 months

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

    4 months

Study Arms (1)

Experimental

EXPERIMENTAL

Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.

Device: BTL-899

Interventions

BTL-899DEVICE

Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.

Experimental

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arm fat layer \> 1.0 cm
  • Age \> 21 years
  • Voluntarily signed an 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 her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

You may not qualify if:

  • Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
  • Metal implants
  • Drug pumps
  • Malignant tumor
  • Pulmonary insufficiency
  • Injured or otherwise impaired muscles
  • 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, and menstruation
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, 60654, United States

Location

Maryland Laser Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Related Publications (1)

  • Jacob C, Weiss RA. Simultaneous HIFEM and Synchronized RF Procedure Can Be Effectively Used for Increasing Muscle Mass and Decreasing Fat in the Upper Arm. J Clin Aesthet Dermatol. 2023 Feb;16(2):50-54.

    PMID: 36909865DERIVED

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

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

October 8, 2020

First Posted

October 22, 2020

Study Start

October 5, 2020

Primary Completion

December 10, 2021

Study Completion

February 10, 2022

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)