Single-Treatment, Study of Percutaneous-Temperature Controlled-RF Electrocoagulation on Axilla Tissue

Exclusion Criteria

• •Subjects presenting with any of the following will not be included in the study
• •Prior use of botulinum toxin injections into axilla within the last 6 months
• •Priory Miradry treatments
• •Prior surgical dissection, curettage or liposuction
• •Current or prior sympathectomy
• •Current or prior laser therapy to axilla for hyperhidrosis
• •Female subject in menopause stage
• •Current use of oral medications such as oxybutynin, glycopyrolate, clonazepam, clonidine, phenoxybenzamine or propranolol
• •Use within 7 days preceding surgery of ibuprofen, , non-steroidal anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia)
• •Subjects who have a pacemaker, implantable defibrillators, metal stents, implants or other monitoring equipment
• •History or current injury to the axilla or nearby anatomical areas.
• •Clinically significant wounds, lesions or acute infections including, dermatitis, lupus or other autoimmune disease affecting the dermis
• •Pregnant or planning pregnancy prior to the end of study participation
• •History or current diagnosis of cancer of any type
• •History of uncontrolled cardiovascular disease(i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease)
• •Known hypersensitivity to local anesthetic medications
• •History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants
• •History of AIDs/HIV
• •Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years
• •Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements
• •Any family member of the investigator or investigational staff, or an employee of the investigator.
• •Participation in any other investigational study within 30 days prior to consent;