Body FatNCT04584099
Multi-Center Traditional Feasibility Study of Radiofrequency Device
A study testing Radiofrequency device treatment in people with Body Fat, run by Cynosure, Inc. at 2 sites in United States.
Trial summary
This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the abdominal area. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Body Fat
- What is being tested?
- Radiofrequency device treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Aug 2020to 14 Jan 2021
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A healthy male or female between the age of 18 - 55 years old.
- Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area.
- 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.
- The subject 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 prior to entering this study.
- The subject has a cut, wound, or infected skin on the area to be treated.
- The subject is on local, oral, or systemic anesthetic agents.
- The subject 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.
- The subject 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.
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- Cautionary Criteria:
- The subject has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment.
- The subject 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 from the Smart Handpiece or surgical handpiece.
- The subject is allergic to adhesives, such as glues on medical tape, they should be alerted that a rash may occur on the neutral pad site and an over the counter solution may be used to treat the area.
- The subject is allergic to gold, such as the metallic covering of the TempSure handpieces.
- The subject is allergic to corn, such as the corn derivative ingredient in Parker Aquasonic Gel.
- If the subject has an unhealthy expectation of the results - this is not plastic surgery and all subject should be fully informed of the treatment's expected results.
- The subject has nerve insensitivity to heat in the treatment area.
- The subject 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.
- The subject has used Accutane (Isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
- Studies of the use of the RF generator on subjects that have any of the following conditions is unknown:
- Autoimmune Disease
- Diabetic
- Herpes Simplex
- Use caution when treating areas that have scars, tattoos, permanent makeup, and permanent brows.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bass Plastic Surgery PLLC
New York, New York, 10065
Aesthetic Pavilion
Staten Island, New York, 103206
About this study
Official title: Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-invasive Lipolysis
This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the abdominal area.
Read the detailed description
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old and are willing to have biopsies taken from a control site and the treatment area. Subjects may be enrolled if they have been previously scheduled or willing to have an abdominoplasty procedure after their participation in the study. A maximum of 20 subjects will be enrolled at up to 4 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the TempSure® Firm on the abdomen or flanks. All subjects will receive a phone call 1 week (1-10 days) post each treatment. Subjects may be asked to return for follow-up visits after their final treatment for incisional biopsies. A follow up may occur at 10, 20, and/or 30 days post their last treatment.
- Conditions
- Body Fat
- Being tested
- Radiofrequency device treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency device treatmentDevice
TempSure firm
| Study group | Role | What they receive |
|---|---|---|
| Biopsy Removed Post Tx | Experimental | All subjects had one radiofrequency treatment before scheduled biopsy or abdominoplasty on tissue to be removed during abdominoplasty immediately post treatment, 10 days post treatment, 20 days post treatment, and/or 30 days post treatment. Receives: Device: Radiofrequency device treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histology of Biopsy
Samples will be assessed independently and may be assessed for normal structures, cell viability, vascular injury, and overall morphologic traits, injury, and any indications of the healing response.
Measured: Up to 30 days post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start25 Aug 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Why it stopped: This study stopped due to 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 Body FatStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Civiok, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584099
- Sponsor's protocol ID
- CYN20-FIRM-HISTO
- Status last verified
- Jun 2023
- First submitted
- 24 Sep 2020
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No data will be shared.
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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-invasive Lipolysis
- ClinicalTrials.gov ID
- NCT04584099
- Acronym / sponsor ID
- CYN20-FIRM-HISTO
- Conditions
- Body Fat
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study stopped due to a business decision.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the abdominal area.
Detailed description
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old and are willing to have biopsies taken from a control site and the treatment area. Subjects may be enrolled if they have been previously scheduled or willing to have an abdominoplasty procedure after their participation in the study. A maximum of 20 subjects will be enrolled at up to 4 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the TempSure® Firm on the abdomen or flanks. All subjects will receive a phone call 1 week (1-10 days) post each treatment. Subjects may be asked to return for follow-up visits after their final treatment for incisional biopsies. A follow up may occur at 10, 20, and/or 30 days post their last treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy Removed Post Tx | Experimental | Device: Radiofrequency device treatmentAll subjects had one radiofrequency treatment before scheduled biopsy or abdominoplasty on tissue to be removed during abdominoplasty immediately post treatment, 10 days post treatment, 20 days post treatment, and/or 30 days post treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A healthy male or female between the age of 18 - 55 years old.
- Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area.
- 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 (23 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.
- The subject 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 prior to entering this study.
- The subject has a cut, wound, or infected skin on the area to be treated.
- The subject is on local, oral, or systemic anesthetic agents.
- The subject 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.
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 |
|---|---|---|
| Radiofrequency device treatmentTempSure firm | Device | Biopsy Removed Post Tx |
Primary outcome
Histology of Biopsy
Time frame: Up to 30 days post last treatment
Samples will be assessed independently and may be assessed for normal structures, cell viability, vascular injury, and overall morphologic traits, injury, and any indications of the healing response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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. No data will be shared.
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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
Cynosure, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency device treatment in people with Body Fat, run by Cynosure, Inc. 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 23 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 15 Jun 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?
Yes. Results are posted in the registry (first posted 15 Jun 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?
Histology of Biopsy (time frame: Up to 30 days post last treatment). 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 NCT04584099, 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 15 Jun 2023.