Research on Current Prototypes of the Digiclamp. Short Term and Long Term Outcomes of Treating Adults With Achrocordons (Skin Tags)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Re-occurrence Rate of Skin Tags
研究概览
简要总结
The objective of this study is to assess the efficacy of using the Digiclamp device to remove achrocordons (skin tags). The hypothesis is that utilizing the device will result in low rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.
详细描述
Achrocorodons, or skin tags, are superficial cutaneous lesions that occur most commonly among middle aged adults, obese persons and those who suffer from Type 2 Diabetes. In most cases, the tags are not bothersome but there are instances when they can become infected or irritated. There are several skin tag removal options available, including suture ligature, freezing, cautery or excision. These procedures are often done in a dermatology office and are an out-of-pocket cost.
The Digiclamp device was invented to make skin tag removal procedures more accessible. The Digiclamp represents a new option that when placed in the hands of primary care clinicians, it will allow them to remove skin tags without having to purchase expensive devices or to refer them to a Dermatologist. The device is disposable, and relatively painless when used correctly, and requires minimal training.
The investigator is planning to enroll 100 subjects, who will have skin tags removed using the Digiclamp device. Subjects will return for follow up at 2-3 months after skin tag removal.
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
- •Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the skin tag
排除标准
- •Subjects with skin tags measuring greater than 1 centimeter width at the base
- •Subjects whose skin tags appear infected or may need to be evaluated by pathology
- •Subjects whose skin tags are located in genital areas or eyelids
- •Pregnant subjects
- •Subjects with bleeding disorders.
结局指标
主要结局
Re-occurrence Rate of Skin Tags
时间窗: 3 months
Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.
次要结局
- Percentage of Scar Tissue Formation Among Lesion Sites(3 months)
- Percentage of Discoloration Among Subjects(3 months)
- Satisfaction With Pain Post Procedure(2 months post procedure)
- How Likely to Recommend the Procedure to Friends and Family(2 months post procedure)
- Percentage of Pain/Numbness Where Skin Tag Was Removed(3 months)
- Satisfaction With What the Area Looked Like Post Procedure(2 months post procedure)
- Percentage of Permanent Scars Among Lesion Sites(3 months)