Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation

NCT06274177 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS1400
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment.

Conditions

Fat Burn

Keywords

submentum; neck rejuvenation; double chin; fat

Outcome Measures

Primary Outcomes (1)

• Submental fat thickness reduction

  The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 mm in the average submental fat layer thickness in the majority of subjects measured by MRI at 3-months follow-up compared to baseline.

  15 months

Secondary Outcomes (5)

• Incidence of Treatment-related Adverse Events

  15 months

• Change on the Clinician Reported - Submental Fat Rating Scale score

  15 months

• Satisfaction Assessed by the Satisfaction Questionnaire

  15 months

• Change in the submental-cervical angle

  15 months

• Comfort Assessed by Therapy Comfort Questionnaire

  15 months

Study Arms (1)

Treatment with BTL-785-7

EXPERIMENTAL

Treatment with BTL-785F device (BTL-785-7 applicator)

Device: BTL-785-7

Interventions

BTL-785-7 DEVICE

Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment

Treatment with BTL-785-7

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects over 21 years of age seeking treatment for reduction of submental fat
• Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
• Presence of clearly visible excess fat in submentum as deemed appropriate by the Investigator
• Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation
• Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken

You may not qualify if:

• Local bacterial or viral infection in the area to be treated
• Local acute inflammation in the area to be treated
• Impaired immune system caused by any immunosuppressive illness, disease or medication
• Isotretinoin and tretinoin-containing medication use in the past 12 months
• Skin related autoimmune diseases
• Radiation therapy and/or chemotherapy
• Poor healing and unhealed wounds in the treatment area
• Metal implants
• Permanent implant in the treated area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
• History of any type of cancer
• Active collagen diseases

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (4)

Precision Skin LLC

Davie, Florida, 33328, United States

Location

Chicago Cosmetic and Dermatologic Research

Chicago, Illinois, 60654, United States

Location

New Jersey Plastic Surgery (NJPS)

Montclair, New Jersey, 07042, United States

Location

Gentile Facial Plastic and Aesthetic Laser Center

Youngstown, Ohio, 44512, United States

Location

MeSH Terms

Conditions

Platelet Glycoprotein IV Deficiency

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: February 7, 2024
• First Posted: February 23, 2024
• Study Start: July 26, 2023
• Primary Completion: August 4, 2024
• Study Completion: September 12, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)