Study To Assess The Safety And Efficacy Of The Tempsure Flexsure Applicators For Abdominal Wrinkles

Prospective Clinical Study To Assess The Safety And Efficacy Of The Tempsure Flexsure Applicators For The Treatment Of Abdominal Wrinkles

Subjects will be enrolled at 1 study center. Subjects may receive 5 treatments with the TempSure® device on the abdomen for wrinkles.

Study Overview

• Status: Terminated
• Conditions: Wrinkle
• Intervention / Treatment: Device: Treatment with TempSure Applicator

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Juva Skin & Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A healthy, non-smoking male or female between the age of 18 - 55 years old.
• Willing to receive treatments with the TempSure® device.
• Understand and accept obligation not to receive any other procedures on the treatment and control area throughout 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 child bearing 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 nerve insensitivity to heat in the treatment area.
• 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.

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.
• 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 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 britlle

• 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 tattoos, permanent makeup, and permanent brows.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TempSure FlexSure Applicator; Subjects will be treated with the TempSure FlexSure applicator device at each treatment.	Device: Treatment with TempSure Applicator; Subjects will receive up to 5 treatments on the abdomen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct Identification of Pre-Treatment Images Compared to Follow Up Images	Blinded independent reviewers will be given pre-treatment and 30 day follow up images and will identify which image is pre-treatment, and which image was taken at the follow up. The percentage of correct images identified will be reported.	30 Day Follow Up
Correct Identification of Pre-Treatment Images Compared to Follow Up Images	Blinded independent reviewers will be given pre-treatment and 90 day follow up images and will identify which image is pre-treatment, and which image was taken at the follow up. The percentage of correct images identified will be reported.	90 Day Follow Up

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: Jennifer Civiok, Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 7027-PL01-2021

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