NCT01261988已完成1 期
A Single Center, Feasibility Study Using Healthy Volunteers to Assess the Safety and Adhesive Performance of the VIPER System When Compared to the Esteem™ Cut to Fit One Piece Closed End Pouch
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety: Related Events
研究概览
简要总结
The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 70 years of age (inclusive) at the time of randomization
- •Willing and able to provide written informed consent and HIPAA Waiver
- •An appropriate candidate for participation with unbroken non-irritated abdominal skin
- •Willing to adhere to the study procedures and to attend the scheduled study visits according to the requirements of the study protocol
- •Willing to adhere to the scheduled study visits
- •Good manual dexterity and be able to take care of their abdominal area independently
- •Be willing and able to record the required study data in a specified format
排除标准
- •A history of a known sensitivity or allergy to System 3+ adhesive (modified Stomahesive® technology), Stomahesive®, Durahesive®, Polyethylene Film, or polyester fiber,or to any adhesive components in general as listed in the Investigators Brochure.
- •Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
- •Subjects with any chronic allergies requiring the use of prescription medication
- •History of skin disease affecting abdominal area
- •Currently uses topical ointments in the area of the abdomen or is unwilling/unable to terminate over the counter use of topical ointments in the area of the abdomen
- •Active case of eczema, dermatitis, psoriasis
- •Pregnant or lactating females.
- •Subject currently enrolled in another investigational study
- •Possesses extensive knowledge about either product (ie employees that re members or extended members of the Core Team work in ostomy research and development, or ostomy division sales and marketing )
结局指标
主要结局
Safety: Related Events
时间窗: 17 hours
All adverse events (AE's) related to the use of the device
Safety: Skin Reactions
时间窗: 17 hours
Efficacy: Device Fall-Offs
时间窗: 17 hours
The number and percentage of subjects with study device fall-off during the study
次要结局
- Adhesive(1 hour)
- Ease of Removal(17 hours)
- Security(17 hours)
研究者
研究点 (2)
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