Clinical Trial: Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).

Detailed Summary:
Sponsor: Miramar Labs

Current Primary Outcome:

• 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 ]
• Rate of serious adverse events [ Time Frame: 12 months post treatment ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Miramar Labs

Dates:
Date Received: March 19, 2010
Date Started: February 2010
Date Completion:
Last Updated: December 5, 2014
Last Verified: December 2014