Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment by the miraDry System can safely reduce the severity of axillary hyperhidrosis (excessive underarm sweating).

Official Title
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Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis

Conditions
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Axillary Hyperhidrosis

Intervention / Treatment
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* Device: miraDry System (treatment with energy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or older at the time of consent. Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale. Subject has a baseline gravimetric measurement of spontaneous resting sweat production of at least 50mg/5min at room temperature in each axilla. Subject has primary focal axillary hyperhidrosis evidenced by at least two of the following: Bilateral and relatively symmetric Impairs daily activities Frequency of at least one episode per week Age of onset less than 25 years old Positive family history Cessation of focal sweating during sleep. In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated. Subject has provided written informed consent using a form that has been approved by the reviewing IRB/ethics committee. Subject is willing and able to comply with protocol requirements and all study visits. Female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study. Exclusion Criteria: Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy. Subject has hyperhidrosis on the trunk or chest. Subject has evidence of active infection. Prior endoscopic thoracic sympathectomy, liposuction or other surgery for axillary hyperhidrosis. Axillary injection of botulinum toxin within one year preceding the miraDry treatment. Oral anticholinergic medication use (e.g., Robinul) or cholomimetic medication use within the last 4 weeks or planned use during the study's follow up phase. Subject is a prisoner or under incarceration. Currently participating in or recently participated in another clinical trial (within the last 30 days). History of or current neurologic deficit in the treatment limb. Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine). History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) subjects with a history of successfully treated cancer that have been disease-free for five years. Injury in the treatment area, shoulder or limb, which, in the opinion of the physician would render this subject an unacceptable candidate for DTS treatment (e.g., prior surgical repair, injury of the shoulder requiring physical therapy). Subject has a pacemaker, defibrillator or other electronic implant Subject requires supplemental oxygen.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with the miraDry System in both axilla | Device: miraDry System (treatment with energy)<br>* Treatment with microwave energy delivery device as specified by manufacturer's instructions<br>* Other names: miraDry System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects that rate themselves as HDSS of 1 or 2 at the 30 day follow-up visit will be greater than 50% with a 95% confidence. |  | 30 days after final treatment session | 
| Rate of serious adverse events |  | 12 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperhidrosis