Hyperhidrosis Clinical Trial
Official title:
Post-market Clinical Investigation of High-Volume Anesthesia (Local Tumescent Anesthesia) Used With the miraDry Treatment for Axillary Hyperhidrosis
NCT number | NCT05546710 |
Other study ID # | CP-0024 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2022 |
Est. completion date | December 2023 |
Verified date | October 2023 |
Source | miraDry, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults (aged =18 years) at time of consent. 2. A HDSS score of 3 or 4. 3. 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: 1. A cardiac pacemaker or cardiac defibrillator or other electronic implant. 2. Requires supplemental oxygen. 3. Known resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine. 4. Secondary excess sweating due to medications, infections, malignancy. 5. Evidence of active infection or prone to infection. 6. Prior liposuction or other dissection surgery for axillary excess sweating. 7. 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. 8. Taking any other medication that may hinder post-procedure recovery and/or healing. 9. Botulinum treatment of the axilla within the last 12 months. 10. Currently participating in or recently participated in another clinical trial (within the last 30 days). 11. History of or current neurologic deficit in the treatment area and/or limb. 12. 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. 13. Any history of cysts, hidradenitis suppurativa, etc. 14. Pre-existing conditions at the time of enrollment that overlap with the list of anticipated AEs (Section 6.1). 15. Prior treatment in axillary area with miraDry. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
miraDry, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of device and/or treatment related serious adverse events (SAEs) | Incidence of device and/or treatment related serious adverse events (SAEs) | 30 days | |
Primary | 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 | Incidence of device and/or treatment related SAEs and AEs | Incidence of device and/or treatment related SAEs and AEs | 6 months | |
Secondary | Responder rate: HDSS score of 1 or 2 | Responder rate: HDSS score of 1 or 2 | 3 and 6 months | |
Secondary | 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 | |
Secondary | Change in odor assessment score from baseline | Change in odor assessment score from baseline | 30 days, 3 months, and 6 months |
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