The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments
研究概览
简要总结
Patients with excessive underarm odor and sweating and/or odor are treated with the VASER system to determine the VASER's effectiveness in reducing underarm sweat and odor
详细描述
Patients with excessive underarm sweat and/or odor are recruited. The effect that excessive underarm sweat and/or odor has on their lifestyle is evaluated. They are surgically treated with the VASER system and followed up for 6 months to evaluate side effects, adverse events and effectiveness. Additional lifestyle evaluations are completed for comparison to pre-surgery answers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Willing and able to appear for all scheduled, post-operative visits
- •Have axillary hyperhidrosis/bromidrosis that does not respond to conventional, non-invasive treatment
排除标准
- •under the age of 18
- •have undergone a prior surgical intervention for treatment of axillary hyperhidrosis (e.g.) Skoog procedure, ETS)
- •have been treated with a systemic or topical agent for axillary hyperhidrosis in the past 30 days
- •are deemed inappropriate candidates for surgery due to medical or mental health reasons
- •are currently being treated with investigational agents or have participated in an investigational study within 60 days prior to surgery
- •elect not to participate in the study
结局指标
主要结局
To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments
时间窗: 6 months
To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment
时间窗: 6 months
次要结局
- To assess patient's post-operative pain level following VASER using patient self report assessments.(2 months)
- To assess patients healing time following VASER treatment of axillary hyperhidrosis(6 months)
- To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER(6 months)