Clinical trial NCT05166824: Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device
Official title: Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Heating
Coagulation
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-22
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Subject Satisfaction
timeFrame: 30 days post final treatment
measure: Number of Tissue Samples With Successful Results
timeFrame: Immediately Post Treatment (Same Day)
Secondary outcomes:
Other outcomes:
Locations:
city: Westford
country: United States
facility: Cynosure
state: Massachusetts
city: Portsmouth
country: United States
facility: Excellent Vision
state: New Hampshire
city: Montclair
country: United States
facility: New Jersey Plastic Surgery
state: New Jersey
city: Huntersville
country: United States
facility: Saluja Cosmetic and Laser Center
state: North Carolina
city: Knoxville
country: United States
facility: Institute of Female Pelvic Medicine
state: Tennessee
Study officials:
affiliation: Cynosure, Inc.
name: Jennifer Civiok
role: STUDY_DIRECTOR
affiliation: Cynosure, Inc.
name: Sean Doherty
role: PRINCIPAL_INVESTIGATOR
affiliation: Saluja Cosmetic and Laser Center
name: Raminder Saluja
role: PRINCIPAL_INVESTIGATOR
affiliation: New Jersey Plastic Surgery
name: Barry DiBernardo
role: PRINCIPAL_INVESTIGATOR
affiliation: Excellent Vision
name: Edward Jaccoma
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Female Pelvic Medicine
name: Jeffrey Dell
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.