Clinical trial NCT04930705: Study To Assess The Safety And Efficacy Of The Tempsure Flexsure Applicators For Abdominal Wrinkles
Official title: Prospective Clinical Study To Assess The Safety And Efficacy Of The Tempsure Flexsure Applicators For The Treatment Of Abdominal Wrinkles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wrinkle
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Correct Identification of Pre-Treatment Images Compared to Follow Up Images
timeFrame: 30 Day Follow Up
measure: Correct Identification of Pre-Treatment Images Compared to Follow Up Images
timeFrame: 90 Day Follow Up
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: JUVA Skin & Laser Center
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Jennifer Civiok
role: STUDY_DIRECTOR
References: