Muscle StimulationNCT05388617
Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
A study testing Brera in people with Muscle Stimulation and Abdominal Fat, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The intended use of the device in this study to assess the safety and efficacy of the adhesive electrodes for muscle stimulation and the treatment of abdominal fat on the abdomen and/or flanks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Stimulation, Abdominal Fat
- What is being tested?
- Brera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2022to 24 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A healthy male or female 18 years of age or older.
- Agrees to be treated with the Brera/Med 400 device.
- Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- Understands and accepts the obligation and is logistically able to be present for all visits.
- Is willing to comply with all requirements of the study and sign the informed consent document.
Who cannot join
- Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
- Has injured (such as a cut, wound) or infected skin, or has presence of evident pathologies such as melanomas or other tumors of the skin, dermatitis, eczema, psoriasis, etc. in the area to be treated.
- Is on local, oral, or systemic anesthetic agents.
- Has nerve insensitivity to heat in the treatment area.
- Has received an organ transplant.
Show all 28Show fewer
- Has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment.
- Has an embedded pacemaker or implantable cardioverter defibrillator (ICD), the client's cardiologist must be consulted prior to treatment.
- NOTE: This device has not been tested on patients implanted with electronic devices that receive or emit signals, such as: Pacemakers, Implantable Cardiac Defibrillators (ICD), or Cardiac Resynchronization Therapy (CRT) devices.
- If the neutral pad would need to be placed on a subject that has a metal plate, rod, or any metal implant that could conduct heat.
- Has an allergy to adhesives, such as glues on medical tape, they should be alerted that a rash may occur on the applicator and neutral pad site, and an over-the-counter solution may be used to treat the area.
- Has an unhealthy expectation of the results - this is not plastic surgery and all subjects should be fully informed of the treatment's expected results.
- Has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated - this treatment will be ineffective.
- Has used Accutane (Isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
- Is currently taking anticoagulants.
- The treatment area has scars and/or tattoos.
- Has any of the following conditions:
- Thrombosis or Thrombophlebitis
- Active Vascular Disease
- Labyrinthitis and Tinnitus
- Liver Disease or Dyslipidemias
- Acute Sepsis
- Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
- Cautionary Criteria:
- Has any of the following conditions:
- Autoimmune Disease
- Diabetic
- Herpes Simplex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Study To Assess The Safety And Efficacy Of A Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
The intended use of the device in this study to assess the safety and efficacy of the adhesive electrodes for muscle stimulation and the treatment of abdominal fat on the abdomen and/or flanks.
Read the detailed description
Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 30 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups, Group A and Group B. Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for all visits as outlined in "Schedule of Visits and Procedures - Group A". Subjects will enroll in Group B for training and experience purposes only and will follow the visit schedule as outlined in "Schedule of Visits and Procedures - Group B".
- Conditions
- Muscle Stimulation, Abdominal Fat
- Being tested
- Brera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreraDevice
The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Receives: Device: Brera |
| Group B | Experimental | Subjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group. Receives: Device: Brera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Satisfied
The number of subjects satisfied with their treatment will be reported.
Measured: 30 days follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start10 May 2022
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Why it stopped: This study stopped because of a business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle StimulationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for up to 8 treatment visits spaced approximately 1 week apart. Subjects will enroll in Group B for training and experience purposes only and will be able to attend up to 8 treatments spaced at least 3 days apart.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Civiok, Study director, Director of Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388617
- Sponsor's protocol ID
- MED4-PL01-2022
- Status last verified
- Nov 2023
- First submitted
- 19 May 2022
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
PubMed 31896400
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study To Assess The Safety And Efficacy Of A Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
- ClinicalTrials.gov ID
- NCT05388617
- Acronym / sponsor ID
- MED4-PL01-2022
- Conditions
- Muscle Stimulation, Abdominal Fat
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study stopped because of a business decision.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intended use of the device in this study to assess the safety and efficacy of the adhesive electrodes for muscle stimulation and the treatment of abdominal fat on the abdomen and/or flanks.
Detailed description
Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 30 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups, Group A and Group B. Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for all visits as outlined in "Schedule of Visits and Procedures - Group A". Subjects will enroll in Group B for training and experience purposes only and will follow the visit schedule as outlined in "Schedule of Visits and Procedures - Group B".
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for up to 8 treatment visits spaced approximately 1 week apart. Subjects will enroll in Group B for training and experience purposes only and will be able to attend up to 8 treatments spaced at least 3 days apart.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: BreraSubjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. |
| Group B | Experimental | Device: BreraSubjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A healthy male or female 18 years of age or older.
- Agrees to be treated with the Brera/Med 400 device.
- Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- Understands and accepts the obligation and is logistically able to be present for all visits.
- Is willing to comply with all requirements of the study and sign the informed consent document.
Key exclusion criteria (28 listed)
- Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
- Has injured (such as a cut, wound) or infected skin, or has presence of evident pathologies such as melanomas or other tumors of the skin, dermatitis, eczema, psoriasis, etc. in the area to be treated.
- Is on local, oral, or systemic anesthetic agents.
- Has nerve insensitivity to heat in the treatment area.
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 |
|---|---|---|
| BreraThe applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort. | Device | Group A, Group B |
Primary outcome
Number of Subjects Satisfied
Time frame: 30 days follow up.
The number of subjects satisfied with their treatment will be reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31896400Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
- 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.
Jennifer Civiok study director
Director of Clinical Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brera in people with Muscle Stimulation and Abdominal Fat, run by Cynosure, Inc. at 1 site 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 28 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: stopped early, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Satisfied (time frame: 30 days follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388617, which also lists 1 linked publication.
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 29 Nov 2023.