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Trial record 72 of 166 for:    "Sweat Gland Disease"

Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091129
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):
Miramar Labs

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Axillary Hyperhidrosis Device: miraDry System (treatment with energy) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Treatment
Treatment with the miraDry System in both axilla
Device: miraDry System (treatment with energy)
Treatment with microwave energy delivery device as specified by manufacturer's instructions
Other Name: miraDry System

Primary Outcome Measures :
  1. 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. [ Time Frame: 30 days after final treatment session ]
  2. Rate of serious adverse events [ Time Frame: 12 months post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091129

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Canada, British Columbia
Guildford Dermatology Specialists
Surrey, British Columbia, Canada, V3R 6A7
Victoria, British Columbia, Canada, V8R 6V4
Sponsors and Collaborators
Miramar Labs
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Principal Investigator: Chih-ho Hong, MD Guildford Dermatology Specialists

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Responsible Party: Miramar Labs Identifier: NCT01091129     History of Changes
Other Study ID Numbers: CP-0004
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Miramar Labs:

Additional relevant MeSH terms:
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Sweat Gland Diseases
Skin Diseases