WithdrawnNot Applicable

miraDry Post Market Tumescent Anesthesia Study

Stopped: Business decision to pivot priorities

0Started 2022-11

Plain-language summary

This clinical trial will collect data on the safety and efficacy of the miraDry treatment when High Volume Anesthesia (Tumescent Anesthesia) is used as an alternate method of anesthetizing the axilla prior to the miraDry System being used. MiraDry system was FDA cleared in 2011 for the treatment of primary axillary hyperhidrosis. The miraDry system is also CE-marked.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adults (aged ≥18 years) at time of consent.
✓. A HDSS score of 3 or 4.
✓. Excess sweating evidenced by at least two of the following:

Exclusion criteria

✕. A cardiac pacemaker or cardiac defibrillator or other electronic implant.
✕. Requires supplemental oxygen.
✕. Known resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine.
✕. Secondary excess sweating due to medications, infections, malignancy.
✕. Evidence of active infection or prone to infection.
✕. Prior liposuction or other dissection surgery for axillary excess sweating.
✕. Oral anticholinergic medication use (e.g., Glycopyrrolate) or cholinomimetic medication use within the last 4 weeks or planned use during the study's follow-up phase.
✕. Taking any other medication that may hinder post-procedure recovery and/or healing.

What they're measuring

Incidence of device and/or treatment related serious adverse events (SAEs)

Timeframe: 30 days

Responder rate: defined as a study participant that reports a Hyperhidrosis Severity Scale (HDSS) score of 1 or 2

Timeframe: 30 days

Trial details

NCT IDNCT05546710

SponsormiraDry, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06

View on ClinicalTrials.gov More Hyperhidrosis trials