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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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