Multi-Center Pivotal Study of Radiofrequency Device

June 9, 2022 updated by: Cynosure, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: All study participants
Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control.
Device: TempSure
Non-invasive radiofrequency treatments

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
% 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.
12 Week Follow Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cynosure, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jennifer Civiok, Cynosure, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CYN20-FIRM-LIPO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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