NL-OMON51645撤回4 期
Post-market Clinical Investigation of High-Volume Anesthesia (Local Tumescent Anesthesia) used with the miraDry Treatment for Axillary Hyperhidrosis - miraDry Postmarket Tumescent Anesthesia Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria. Candidates for this study must meet ALL of the following
- •a) Adults (aged >=18 years) at time of consent.
- •b) A HDSS score of 3 or 4.
- •c) 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.
排除标准
- •Exclusion Criteria. Candidates will be excluded if ANY of the following
- •conditions apply:
- •a) A cardiac pacemaker or cardiac defibrillator or other electronic implant.
- •b) Requires supplemental oxygen.
- •c) Known resistance to or history of intolerance of local anesthesia including
- •lidocaine and epinephrine.
- •d) Secondary excess sweating due to medications, infections, malignancy.
- •e) Evidence of active infection.
- •f) Prior liposuction or other dissection surgery for axillary excess sweating.
- •g) 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.
- •h) Botulinum treatment of the axilla within the last 12 months.
- •i) Currently participating in or recently participated in another clinical
- •trial (within the last 30 days).
- •j) History of or current neurologic deficit in the treatment area and/or limb.
- •k) 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.
研究者
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