miraDry Post Market Tumescent Anesthesia Study

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05546710
Study type	Interventional
Source	miraDry, Inc.
Contact
Status	Withdrawn
Phase	N/A
Start date	November 2022
Completion date	December 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04924036` - Qbrexza Cloths for Hyperhidrosis of Amputation Sites	Phase 2
Recruiting	`NCT05102396` - Topical Oxybutynin for Treatment of Hyperidrosis: Local or Systemic Effect?	Phase 2
Recruiting	`NCT04178161` - Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis	N/A
Completed	`NCT02552199` - A Non-Interventional Study To Assess Sweating
Completed	`NCT02565732` - Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis	Phase 2
Recruiting	`NCT01930604` - Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis	Phase 2
Completed	`NCT01811004` - Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis	N/A
Completed	`NCT01671800` - Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating	Phase 1
Completed	`NCT01956591` - Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis	N/A
Completed	`NCT01934153` - Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects	Phase 1
Completed	`NCT06113978` - Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Patients Below 18	N/A
Completed	`NCT05247333` - Implementation of a Minor Ailment Service in Community Pharmacy Practice	N/A
Completed	`NCT04906655` - An Open Label Study for Palmar Hyperhydrosis	Phase 2
Completed	`NCT02563899` - Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary Hyperhidrosis	Phase 2
Completed	`NCT02016885` - A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis	Phase 2
Completed	`NCT00168480` - A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis	Phase 4
Completed	`NCT03416348` - Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2	Phase 1
Completed	`NCT02973659` - The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.	N/A
Recruiting	`NCT05805696` - Treatment and Mapping of Impostor Phenomenon	N/A
Completed	`NCT03816046` - Hyperhydrosis Treatment Using Botulinum Toxin	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.