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miraDry Post Market Tumescent Anesthesia Study

Primary Purpose

Hyperhidrosis, Axillary Hyperhidrosis

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

miraDry treatment

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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:

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.
Botulinum treatment of the axilla within the last 12 months.
Currently participating in or recently participated in another clinical trial (within the last 30 days).
History of or current neurologic deficit in the treatment area and/or limb.
History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) a history of successfully treated cancer that have been disease-free for five years.
Any history of cysts, hidradenitis suppurativa, etc.
Pre-existing conditions at the time of enrollment that overlap with the list of anticipated AEs (Section 6.1).
Prior treatment in axillary area with miraDry.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

miraDry treatment

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Incidence of device and/or treatment related SAEs and AEs

Responder rate: HDSS score of 1 or 2

Change in Quality of Life from baseline as measured by the Dermatology Life Quality Index (DLQI)

Change in odor assessment score from baseline

Full Information

NCT ID

NCT05546710

First Posted

September 14, 2022

Last Updated

October 19, 2023

Sponsor

miraDry, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05546710

Brief Title

miraDry Post Market Tumescent Anesthesia Study

Official Title

Post-market Clinical Investigation of High-Volume Anesthesia (Local Tumescent Anesthesia) Used With the miraDry Treatment for Axillary Hyperhidrosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Business decision to pivot priorities

Study Start Date

November 2022 (Anticipated)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

miraDry, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperhidrosis, Axillary Hyperhidrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, single-arm, open-label, multicenter study

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

miraDry treatment

Intervention Type

Device

Intervention Name(s)

miraDry treatment

Other Intervention Name(s)

Tumescent Anesthesia (high-volume anesthesia)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

30 days

Title

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

Description

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

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Incidence of device and/or treatment related SAEs and AEs

Description

Incidence of device and/or treatment related SAEs and AEs

Time Frame

6 months

Title

Responder rate: HDSS score of 1 or 2

Description

Responder rate: HDSS score of 1 or 2

Time Frame

3 and 6 months

Title

Change in Quality of Life from baseline as measured by the Dermatology Life Quality Index (DLQI)

Description

Change in Quality of Life from baseline as measured by the Dermatology Life Quality Index (DLQI)

Time Frame

30 days, 3 months, and 6 months

Title

Change in odor assessment score from baseline

Description

Change in odor assessment score from baseline

Time Frame

30 days, 3 months, and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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: 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. Botulinum treatment of the axilla within the last 12 months. Currently participating in or recently participated in another clinical trial (within the last 30 days). History of or current neurologic deficit in the treatment area and/or limb. History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) a history of successfully treated cancer that have been disease-free for five years. Any history of cysts, hidradenitis suppurativa, etc. Pre-existing conditions at the time of enrollment that overlap with the list of anticipated AEs (Section 6.1). Prior treatment in axillary area with miraDry.

12. IPD Sharing Statement

Learn more about this trial

miraDry Post Market Tumescent Anesthesia Study

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