Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis
NCT ID: NCT01091129
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2010-02-28
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Treatment with the miraDry System in both axilla
miraDry System (treatment with energy)
Treatment with microwave energy delivery device as specified by manufacturer's instructions
Interventions
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miraDry System (treatment with energy)
Treatment with microwave energy delivery device as specified by manufacturer's instructions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Miramar Labs
INDUSTRY
Responsible Party
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Principal Investigators
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Chih-ho Hong, MD
Role: PRINCIPAL_INVESTIGATOR
Guildford Dermatology Specialists
Locations
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Guildford Dermatology Specialists
Surrey, British Columbia, Canada
Cosmedica
Victoria, British Columbia, Canada
Countries
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Other Identifiers
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CP-0004
Identifier Type: -
Identifier Source: org_study_id