Body FatNCT04569253

Multi-Center Pivotal Study of Radiofrequency Device

A study testing TempSure in people with Body Fat, run by Cynosure, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 flank (love handle) area. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Body Fat
What is being tested?: TempSure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 6 sitesUnited States
Study dates: 28 Jul 2020to 26 Mar 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
Healthy volunteers accepted
Adult

Who may be able to join

A healthy male or female between the age of 18 - 55 years old.
Willing to undergo treatments for fat reduction of the flank area (love handle)
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 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.
Cautionary Criteria:

Show all 20Show fewer

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

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Maryland Dermatology Laser, Skin, & Vein Institute, LLC.
Hunt Valley, Maryland, 21030
Saluja Cosmetic and Laser Center
Huntersville, North Carolina, 28078
JUVA Skin & Laser Center
New York, New York, 10022
Dermatology Associates of Plymouth Meeting, P.C.
Plymouth Meeting, Pennsylvania, 19462
Jeremy A Brauer MD PC
Rye, New York, 10580
McDaniel Institute of Anti-Aging Research
Virginia Beach, Virginia, 23462

Other trials in United States

About this study

Official title: Clinical Study to Assess the Safety and Efficacy of the Tempsure® Firm for Non-invasive Lipolysis of the Flanks.

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 flank (love handle) area.

Read the detailed description

Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. A maximum of 55 subjects will be enrolled at up to 6 study centers. Subjects will receive up to 5 treatments with the TempSure® Firm on one flank. The other flank will be left untreated to serve a control. Subject will be required to return for follow-up visits at 6 weeks and at 12 weeks after the subject's final treatment. All subjects will receive a phone call 1 week (1-10 days) post each treatment.

Conditions: Body Fat
Being tested: TempSure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TempSureDevice
Non-invasive radiofrequency treatments

Study groups in NCT04569253
Study group	Role	What they receive
All study participants	Experimental	Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control. Receives: Device: TempSure

What is being measured

The primary outcome is the main question the study is designed to answer.

% of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline
Correct identification of pre-treatment images vs. the 12-week follow up images by blinded evaluators.
Measured: 12 Week Follow Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202026 Mar 2021

First posted29 Sep 2020
Study start28 Jul 2020
Primary completion26 Mar 2021
Study completion26 Mar 2021

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04569253
Sponsor's protocol ID: CYN20-FIRM-LIPO
Status last verified: Jun 2022
First submitted: 27 Aug 2020
Last updated: 14 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Assess the Safety and Efficacy of the Tempsure® Firm for Non-invasive Lipolysis of the Flanks.
ClinicalTrials.gov ID: NCT04569253
Acronym / sponsor ID: CYN20-FIRM-LIPO
Conditions: Body Fat
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: 28 Jul 2020 (actual)
Primary completion: 26 Mar 2021 (actual)
Study completion: 26 Mar 2021 (actual)
First posted: 29 Sep 2020 (actual)
Results: Posted 14 Jun 2022

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 flank (love handle) area.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All study participants	Experimental	Device: TempSureSubjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

A healthy male or female between the age of 18 - 55 years old.
Willing to undergo treatments for fat reduction of the flank area (love handle)
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 (20 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 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.

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
TempSureNon-invasive radiofrequency treatments	Device	All study participants

Primary outcome

% of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline
Time frame: 12 Week Follow Up
Correct identification of pre-treatment images vs. the 12-week follow up images by blinded evaluators.

Results and safety

Results posted to the registry on 14 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	65	57

Primary outcome: % of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline

Time frame: 12 Week Follow Up. Number. Unit: % of photos identified correctly

Measure	All Subject Participants n = 56
Value	57

Population analysed: 1 subject attended the 12 week follow up so was considered complete, but did not have pictures taken for this outcome measure.

Adverse events

Time frame: Adverse events were collected throughout subject participation in the study, approximately 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RF Device	0 of 65 (0%)	10 of 65 (15.4%)	0 of 65
Control	0 of 65 (0%)	0 of 65 (0%)	0 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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.

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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.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TempSure in people with Body Fat, run by Cynosure, Inc. at 6 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 20 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 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 14 Jun 2022). 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?

% of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline (time frame: 12 Week 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 NCT04569253, 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 14 Jun 2022.