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Business decision to pivot priorities
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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.
Hyperhidrosis is a condition defined as sweating beyond what is physiologically required by the body (excessive sweating). Hyperhidrosis sufferers have been shown to suffer from anxiety, social and occupational impairment and limitation of exercise, recreation, and leisure. In addition to psychological and social issues, hyperhidrosis sufferers see significant financial burden from their condition. The costs of treatments which need to be repeated chronically and replacing clothing which is permanently stained and unwearable can amount to significant expenditures over time.
Many physicians using the miraDry System are using alternative methods for anesthetizing the axilla; the most common is infiltrative local tumescent anesthesia (LTA) at a high volume. miraDry often calls this method as High Volume Anesthesia (HVA) and the two terms are used interchangably. Tumescent anesthesia is commonly used for various dermatologic surgery procedures. This method involves using a larger volume of fluid with a lower concentration of lidocaine; the fluid is introduced under the skin through a few small injection sites and infiltrated into the desired region. For this application using the tumescent technique, between 100 and 300 cc's of fluid per axilla would be introduced subcutaneously, depending on the size of the axilla.
This clinical trial will collect data on the safety and efficacy when High Volume Anesthesia is used as an alternate method of anesthetizing the axilla prior to the miraDry System being used. The investigators participating in this study are experts in the administration of tumescent anesthesia for dermatologic applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | miraDry treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miraDry treatment | Device | The miraDry device is non-invasive and uses microwave energy, focused at the dermal/hypodermal interface, to thermally impact the sweat glands. The treatment area is identified (hair bearing area of the axilla) and high-volume anesthesia is delivered. The miraDry template is selected based upon the size of the treatment area and temporarily applied to the patient's skin. A new miraDry bioTip is attached to the miraDry Handpiece for each treatment session. The Handpiece is then placed on the surface of the skin in the area to be treated. The treatment cycle is activated by a button on the Handpiece. Multiple placements of the Handpiece are required to treat a full axilla in one treatment session. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device and/or treatment related serious adverse events (SAEs) | Incidence of device and/or treatment related serious adverse events (SAEs) | 30 days |
| Responder rate: defined as a study participant that reports a Hyperhidrosis Severity Scale (HDSS) score of 1 or 2 | Responder rate: defined as a study participant that reports a Hyperhidrosis Severity Scale (HDSS) score of 1 or 2 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device and/or treatment related SAEs and AEs | Incidence of device and/or treatment related SAEs and AEs | 6 months |
| Responder rate: HDSS score of 1 or 2 | Responder rate: HDSS score of 1 or 2 |
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Inclusion Criteria:
a. Impairs daily activities b. Frequency of at least one episode per week c. Age of onset less than 25 years old d. Positive family history e. Cessation of focal sweating during sleep d) In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated.
e) Willing and able to comply with protocol requirements and all study visits. f) Female patients 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:
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Prospective, single-arm, open-label, multicenter study
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| 3 and 6 months |
| Change in Quality of Life from baseline as measured by the Dermatology Life Quality Index (DLQI) | Change in Quality of Life from baseline as measured by the Dermatology Life Quality Index (DLQI) | 30 days, 3 months, and 6 months |
| Change in odor assessment score from baseline | Change in odor assessment score from baseline | 30 days, 3 months, and 6 months |