Actively Recruiting
Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions
Led by Cynosure, Inc. · Updated on 2024-05-07
20
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of the Potenza device used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
CONDITIONS
Official Title
Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy, non-smoking male or female aged 22 to 65 years
- Fitzpatrick skin type I to VI
- Willing to avoid other procedures on the treatment area during the study
- Able and willing to attend all study visits
- Willing to comply with study requirements and sign informed consent
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy without effective birth control
- Enrolled in another investigational drug or device trial or treated with such in the treatment area within 1 month
- Presence of pacemaker or cardiac defibrillator devices
- Prior use of gold thread skin rejuvenation
- Cut, wound, or infected skin in the treatment area (except skin eruptions)
- Metal implants interfering with electrical energy transmission
- Allergy to medical adhesives or gold
- Unrealistic expectations about treatment results
- Nerve insensitivity to heat in treatment or pad area
- Severe skin laxity causing folds or hanging skin in the treatment area
- Use of Accutane within 6 to 12 months
- Use of aspirin, antiplatelets, thrombolytics, anti-inflammatories, or anticoagulants
- History of bleeding disorders
- Allergy to topical anesthetics
- History of diabetes, epilepsy, autoimmune disease, herpes simplex, HIV, hypertension, or dermatitis
- Keloid formation tendency
- Any condition posing significant risk or interference as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cynosure, Inc.
Westford, Massachusetts, United States, 01886
Actively Recruiting
Research Team
J
Jamie Trimper
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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