miraDry Post Market Tumescent Anesthesia Study

NCT05546710 | Withdrawn FDA Device

• 1 other identifier: CP-0024
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperhidrosis; Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Incidence of device and/or treatment related SAEs and AEs

  6 months

• Responder rate: HDSS score of 1 or 2

  3 and 6 months

• 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

  30 days, 3 months, and 6 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

miraDry treatment

Device: miraDry treatment

Interventions

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.

Also known as: Tumescent Anesthesia (high-volume anesthesia)

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• miraDry, Inc.: lead

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, open-label, multicenter study

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10