Radiofrequency and Targeted Pressure Energy for Cellulite Reduction

NCT ID: NCT05624216

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2021-10-25

Brief Summary

This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.

Detailed Description

This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.

At the baseline visit subject's weight will be recorded, together with hip and thigh circumference. In addition, photographs of the treated area will be taken.

The treatment administration phase will consist of four (4) treatments, delivered in 2-4 weeks. The applicator will be applied over the treatment area.

At the last therapy visit, the subject's weight will be recorded, together with hip and thigh circumference. Photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in.

Safety measures will include documentation of adverse events (AE). Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

Conditions

Cellulite; Cellulitis; Cellulitis of Leg

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BTL-084 Treatment

Radiofrequency and targeted pressure energy devices for the treatment of cellulite

Group Type: EXPERIMENTAL

BTL-084

Intervention Type: DEVICE

Radiofrequency and targeted pressure energy devices for the treatment of cellulite

Interventions

BTL-084

Radiofrequency and targeted pressure energy devices for the treatment of cellulite

Intervention Type: DEVICE

Other Intervention Names

Emtone

Eligibility Criteria

Inclusion Criteria

• Voluntarily signed informed consent form
• Age ≥ 21 years
• Subject suffer from Grade 2 or Grade 3 cellulite as per Nürnberger-Muller Scale
• Subject did not experience weight change exceeding 2.5 kg (5 lb) in the preceding month
• BMI ≤ 33 kg/m2
• Women of childbearing 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 skin tightening and cellulite reduction during study participation
• Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

Exclusion Criteria

• Bacterial or viral infection, acute inflammations
• Impaired immune system
• Autoimmune disease
• Diabetes
• Herpes Simplex
• Isotretinoin in the past 12 months
• Scleroderma
• Radiation therapy
• Burns in the treatment area
• Poor healing in the treatment area
• Metal implants
• Implantable pacemaker or automatic defibrillator / cardioverter
• Ablative / non-ablative cosmetic intervention (deep peeling) in the past 3 months
• Cancer and tumor diseases
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
• Pregnancy / nursing or IVF procedure
• Acute neuralgia and neuropathy
• Blood disorders, risk of bleeding, bleeding tissues, peptic ulcers
• Eczema
• Rosacea
• Febrile conditions
• Kidney or liver failure
• Pronounced edemas, ascites, exudates
• Sensitivity disorders in the treatment area
• Varicose veins
• Local corticosteroid therapy

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BTL Industries Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. Busso Cosmetic Dermatology

Coconut Grove, Florida, United States

Countries

United States

Other Identifiers

BTL-084_100

Identifier Type: -

Identifier Source: org_study_id