Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device

Cynosure, Inc.5 sites in 1 country89 target enrollmentJanuary 18, 2017

ConditionsTissue Heating Coagulation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tissue Heating
Sponsor: Cynosure, Inc.
Enrollment: 89
Locations: 5
Primary Endpoint: Subject Satisfaction
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to develop parameters and assess the safety of the radiofrequency device for a variety of treatments. Treatment results were also evaluated.

Registry

clinicaltrials.gov

Start Date

January 18, 2017

End Date

February 4, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cynosure, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A healthy male or female 18 years of age or older.
•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 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 course of the study.
•The subject has active or localized systemic infections.
•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.
•Any other types of cosmetic treatments in the area to be treated in the past 6 months are cautioned and determined at the discretion of the investigator.
•The subject has a history of keloids.
•The subject has evidence of active systemic or local skin disease that may alter wound healing.
•The subject has scarring or wounds in the treatment area that would interfere with study assessments.
•The subject has a metal implant (such as but not limited to; titanium orbit or metal chin repair) in the face or head that would interfere with study treatment, or subject has an electronic implantable device (such as but not limited to; pacemakers and embedded defibrillators).
•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.

Outcomes

Primary Outcomes

Subject Satisfaction

Time Frame: 30 days post final treatment

The subject will be asked their level of satisfaction using a 6-point Likert scale that ranges from "extremely satisfied" to "extremely unsatisfied," with 1 being extremely unsatisfied and 6 being extremely satisfied.

Number of Tissue Samples With Successful Results

Time Frame: Immediately Post Treatment (Same Day)

This is the number of tissue samples removed by the device (on 1 subject) that has similar histological results to scalpels and cautery devices currently on the market.