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

Completed · Not applicable

Conditions studied: Tissue Heating, Coagulation

In brief

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.

Key facts

Study ID

NCT05166824

Run by

Cynosure, Inc.

People needed

89

Starts

2017-01-18

Expected to finish

2019-02-04

Last updated by the study team

2022-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cynosure — Westford, Massachusetts, United States
• Excellent Vision — Portsmouth, New Hampshire, United States
• New Jersey Plastic Surgery — Montclair, New Jersey, United States
• Saluja Cosmetic and Laser Center — Huntersville, North Carolina, United States
• Institute of Female Pelvic Medicine — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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