Fat NecrosisNCT06152900
Safety and Efficacy of Electronic Stimulation for Circumferential Reduction and Muscle Toning
A study testing Accufit in people with Fat Necrosis and Muscle Stimulation, run by CynosureLutronic at 2 sites in United States.
Trial summary
Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Necrosis, Muscle Stimulation
- What is being tested?
- Accufit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2021to 20 Nov 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, understand and voluntarily provide written informed consent.
- Healthy male or female, ≥ 18 years to 65 years of age seeking treatment for improved muscle strength and muscle toning in their core and extremities.
- Subject is determined to be physically fit and agrees to not making any major changes in their diet or lifestyle during the study.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study as well as have a negative Urine Pregnancy test at baseline.
Who cannot join
- Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
- Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
- History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the study.
- History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or premalignant pigmented lesions.
- Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone in the treatment area.
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- Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections.
- Poor skin quality (severe laxity).
- Abdominal wall, muscular abnormality or hernia on physical examination.
- As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
- Subjects unwilling or unable to adhere to all study requirements for treatment and follow-up.
- Investigator may exclude any subject at any time at his/her discretion.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lutronic US Headquarters
Billerica, Massachusetts, 01821
Union Square Dermatology
New York, New York, 10003
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of Electronic Stimulation for Non-Invasive Circumferential Reduction and Muscle Toning
Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Each subject will receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2, 30- and 90-days post treatment. Measurement outcomes will be compared to baseline.
- Conditions
- Fat Necrosis, Muscle Stimulation
- Being tested
- Accufit
- Medical subject headings
- Fat Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccufitDevice
Also called ME Sys*STIM 240
Magnet-based and Direct muscle stimulation devices are commonly used to generate current flow through the muscles in order to activate the muscle. The Accufit Electrical Muscle Stimulation device is an FDA cleared device having a two-channel stimulator that provides up to 8 electrodes with waveforms of interferential and biphasic for muscle stimulation. The Accufit system is indicated for relaxation of muscles, muscle re-education, reduction of pain and increased local blood circulation.
Muscle stimulation technology has been around for many decades and has been shown to be safe and effective for a variety of clinical applications. The foundational basis for the technology revolves around electrical current flowing through the muscle can be used to activate the muscle.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | All subjects enrolled in the study will be placed into the treatment arm of the study, to be treated by the Accufit device. Receives: Device: Accufit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Evaluation
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at follow up visits (48 hours, 30 days, 90 days).Results will be reported as a % of the correctly identified post treatment photographs chosen per Blinded Reviewer. An average of the % of the correctly identified post treatment photographs chosen by Blinded Reviewer will be calculated and used to determine efficacy.
Measured: Baseline, 48-hours post treatment, 30-day FU, 90-day FU
Secondary outcomes (4)
Circumferential Reduction
Reduction in circumference as measured by Seca Circumferential System at follow up visits compared to baseline measurement. Measurements were taken of the right and left arm in both a relaxed and engaged position.
Measured: Baseline, 30-day FU, 90-day FU
Subject Satisfaction
Assess subject satisfaction using Satisfaction survey at each follow up visit. Scores available in the scale include the following:
- - Very Satisfied
- - Satisfied
- - Neutral
- - Dissatisfied
Measured: 30-day FU, 90-day FU
Global Aesthetic Improvement Scale
A scale to assess the overall improvement in a subject's condition in an unblinded fashion. Choices on the scale include the following:
- - Very Much Improved
- - very Improved
- - Improved
- - No Change
- - Worsened
Measured: 30-day FU, 90-day FU
Muscle Strength
Improvement in muscle strength of the treated extremity as measured by a dynamometer at follow up visits compared to baseline measurements. Subjects are asked to hold onto a handheld device which will then be used to measure the strength of the bicep and tricep muscles.
Measured: Baseline, 30-day FU, 90-day FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start5 Oct 2021
- Primary completion20 Nov 2022
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat NecrosisStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152900
- Sponsor's protocol ID
- AFL19006
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD Sharing planned at this time.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of Electronic Stimulation for Non-Invasive Circumferential Reduction and Muscle Toning
- ClinicalTrials.gov ID
- NCT06152900
- Acronym / sponsor ID
- AFL19006
- Conditions
- Fat Necrosis, Muscle Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 1 Dec 2023 (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.
Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Each subject will receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2, 30- and 90-days post treatment. Measurement outcomes will be compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: AccufitAll subjects enrolled in the study will be placed into the treatment arm of the study, to be treated by the Accufit device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to read, understand and voluntarily provide written informed consent.
- Healthy male or female, ≥ 18 years to 65 years of age seeking treatment for improved muscle strength and muscle toning in their core and extremities.
- Subject is determined to be physically fit and agrees to not making any major changes in their diet or lifestyle during the study.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study as well as have a negative Urine Pregnancy test at baseline.
Key exclusion criteria (12 listed)
- Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
- Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
- History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the study.
- History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or premalignant pigmented lesions.
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 |
|---|---|---|
| AccufitAlso: ME Sys*STIM 240Magnet-based and Direct muscle stimulation devices are commonly used to generate current flow through the muscles in order to activate the muscle. The Accufit Electrical Muscle Stimulation device is an FDA cleared device having a two-channel stimulator that provides up to 8 electrodes with waveforms of interferential and biphasic for muscle stimulation. The Accufit system is indicated for relaxation of muscles, muscle re-education, reduction of pain and increased local blood circulation. Muscle stimulation technology has been around for many decades and has been shown to be safe and effective for a variety of clinical applications. The foundational basis for the technology revolves around electrical current flowing through the muscle can be used to activate the muscle. | Device | Treatment Arm |
Primary outcome
Photographic Evaluation
Time frame: Baseline, 48-hours post treatment, 30-day FU, 90-day FU
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at follow up visits (48 hours, 30 days, 90 days).Results will be reported as a % of the correctly identified post treatment photographs chosen per Blinded Reviewer. An average of the % of the correctly identified post treatment photographs chosen by Blinded Reviewer will be calculated and used to determine efficacy.
4 secondary outcomes
Circumferential Reduction
Time frame: Baseline, 30-day FU, 90-day FU
Subject Satisfaction
Time frame: 30-day FU, 90-day FU
Global Aesthetic Improvement Scale
Time frame: 30-day FU, 90-day FU
Muscle Strength
Time frame: Baseline, 30-day FU, 90-day FU
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 1 Dec 2023.
- Individual participant dataSharing planned: No. No IPD Sharing planned at this time.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accufit in people with Fat Necrosis and Muscle Stimulation, run by CynosureLutronic at 2 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 12 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Photographic Evaluation (time frame: Baseline, 48-hours post treatment, 30-day FU, 90-day FU). 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 1 Dec 2023.