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

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.

Study Overview

• Status: Completed
• Conditions: Coagulation; Tissue Heating
• Intervention / Treatment: Device: TempSure; Device: Scalpel; Device: Bovie; Device: Pelleve

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Westford, Massachusetts, United States, 01886
      • Cynosure
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Excellent Vision
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Saluja Cosmetic and Laser Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37932
      • Institute of Female Pelvic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical- abdominoplasty; Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the abdomen. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.	Device: TempSure; Radiofrequency platform; Device: Scalpel; Cold knife; Device: Bovie; Electrosurgery and electrocautery platform
Experimental: Women's Health; Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.	Device: TempSure; Radiofrequency platform
Experimental: Skin Rejuvenation; The hand piece, applicator or tip was placed in contact with the skin. The entire defined treatment area was treated by delivering energy to the skin. The hand piece, number of passes and parameters used for the treatment was determined by the Investigator.	Device: TempSure; Radiofrequency platform; Device: Pelleve; Radiofrequency platform
Experimental: Surgical- blepharoplasty; Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the eyelids. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.	Device: TempSure; Radiofrequency platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction	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.	30 days post final treatment
Number of Tissue Samples With Successful Results	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.	Immediately Post Treatment (Same Day)

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: Jennifer Civiok, Cynosure, Inc.; Principal Investigator: Sean Doherty, Cynosure, Inc.; Principal Investigator: Raminder Saluja, Saluja Cosmetic and Laser Center; Principal Investigator: Barry DiBernardo, New Jersey Plastic Surgery; Principal Investigator: Edward Jaccoma, Excellent Vision; Principal Investigator: Jeffrey Dell, Institute of Female Pelvic Medicine

Publications and helpful links

General Publications

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): February 4, 2019
• Study Completion (Actual): February 4, 2019

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CYN17-RF-CLINIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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