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

Coagulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166824
• Other study ID #: CYN17-RF-CLINIC
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: February 4, 2019

Study information

• Verified date: March 2022
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coagulation

Intervention

Device:
• TempSure
Radiofrequency platform
• Scalpel
Cold knife
• Bovie
Electrosurgery and electrocautery platform
• Pelleve
Radiofrequency platform

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)