Fat BurnNCT06274177
Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation
A study testing BTL-785-7 in people with Fat Burn, run by BTL Industries Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fat Burn
- What is being tested?
- BTL-785-7
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Jul 2023to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
- Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis, hypersensitive carotid sinus and thrombosis)1
- Pregnancy/nursing or IVF procedure
- History of bleeding coagulopathies, use of anticoagulants
- Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
- Any surgical procedure in the treatment area within the last three months or before complete healing
- Poorly controlled endocrine disorders, such as diabetes
- Acute neuralgia and neuropathy
- Kidney or liver failure
- Nerve insensitivity (sensitivity disorders) to heat in the treatment area
- Varicose veins, pronounced edemas1
- Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
- Unwillingness/inability to not change their usual cosmetics and especially not to use fat reduction, anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
- Electroanalgesia without exact diagnosis of pain etiology
- Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
- Blood vessels and lymphatic vessels inflammation
- Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Chicago Cosmetic and Dermatologic Research
Chicago, Illinois, 60654
Precision Skin LLC
Davie, Florida, 33328
New Jersey Plastic Surgery (NJPS)
Montclair, New Jersey, 07042
Gentile Facial Plastic and Aesthetic Laser Center
Youngstown, Ohio, 44512
About this study
Official title: Evaluation of the Safety and Efficacy of the BTL-785F Device for Non-invasive Submental Fat Reduction and Neck Rejuvenation
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.
Read the detailed description
This is a multi center single-arm, open-label, interventional study.
The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart. Follow-ups visits at 1 month and 3 months after the final treatment will be held.
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.
Safety measures will include documentation of adverse events (AE) during and after the procedures and if needed medical assistance.
- Conditions
- Fat Burn
- Being tested
- BTL-785-7
- Keywords
- submentum, neck rejuvenation, double chin, fat
- Medical subject headings
- Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-785-7Device
Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-785-7 | Experimental | Treatment with BTL-785F device (BTL-785-7 applicator) Receives: Device: BTL-785-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (5)
Incidence of Treatment-related Adverse Events
To evaluate the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat through monitoring of adverse reactions.
Measured: 15 months
Change on the Clinician Reported - Submental Fat Rating Scale score
Evaluation of the change in the Clinician Reported - Submental Fat Rating Scale (CR-SMFRS) grade. The scale ranges from grade 0 (no evident submental fat) to grade 4 (extreme submental convexity). Photographs from the last therapy, 1 month and 3 months follow-up will be compared to baseline photographs. An improvement is considered a decrease of the grade in the Clinician Reported - Submental Fat Rating Scale.
Measured: 15 months
Satisfaction Assessed by the Satisfaction Questionnaire
The 5-point Likert scale Subject Satisfaction Questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last therapy, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' under-chin and overall facial appearance will vary from "strongly agree" to "strongly disagree".
Measured: 15 months
Change in the submental-cervical angle
Statistically significant change in submental-cervical angle (SCA) convexity in the majority of the subjects
Measured: 15 months
Comfort Assessed by Therapy Comfort Questionnaire
The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain). The Therapy Comfort questionnaire will be given to subjects after the last therapy.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start26 Jul 2023
- Primary completion4 Aug 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274177
- Sponsor's protocol ID
- BTL-785_CTUS1400
- Status last verified
- Oct 2024
- First submitted
- 7 Feb 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the BTL-785F Device for Non-invasive Submental Fat Reduction and Neck Rejuvenation
- ClinicalTrials.gov ID
- NCT06274177
- Acronym / sponsor ID
- BTL-785_CTUS1400
- Conditions
- Fat Burn
- Keywords
- submentum, neck rejuvenation, double chin, fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 4 Aug 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi center single-arm, open-label, interventional study.
The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart. Follow-ups visits at 1 month and 3 months after the final treatment will be held.
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.
Safety measures will include documentation of adverse events (AE) during and after the procedures and if needed medical assistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-785-7 | Experimental | Device: BTL-785-7Treatment with BTL-785F device (BTL-785-7 applicator) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTL-785-7Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment | Device | Treatment with BTL-785-7 |
Primary outcome
Submental fat thickness reduction
Time frame: 15 months
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.
5 secondary outcomes
Incidence of Treatment-related Adverse Events
Time frame: 15 months
Change on the Clinician Reported - Submental Fat Rating Scale score
Time frame: 15 months
Satisfaction Assessed by the Satisfaction Questionnaire
Time frame: 15 months
Change in the submental-cervical angle
Time frame: 15 months
Comfort Assessed by Therapy Comfort Questionnaire
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL-785-7 in people with Fat Burn, run by BTL Industries Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Submental fat thickness reduction (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.