Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Select Skin Conditions Observed During Securis™ Stabilization Device Use
研究概览
简要总结
This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.
详细描述
This study is designed to collect prospective observational data related to the safety and performance of the Securis™ Stabilization Device in healthy volunteers utilizing a simulated use method. Participants will have an intravenous catheter applied (not inserted) onto their forearm with a Securis™ Stabilization Device applied over it. The site/device will be assessed over a period of 9 days (ideally Days 0-7 in-clinic and Day 8 virtually). The assessments will include the appearance of the site, the appearance of the dressing, and the movement of the catheter tip under the dressing.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥14 years of age, regardless of gender, at the time of informed consent
- •Is expected to be available through Day 8 of the study
- •Is expected to understand and follow the study procedures including applicable restrictions in activities (e.g., limited physical exercise, no swimming, no use of lotions/moisturizers, etc.)
- •Provision of signed and dated informed consent form. Note: Consent of a parent of legal guardian will be require for participants <18 years of age; assent will also be required for these participants
排除标准
- •Significant scarring at the device application site
- •Has any skin condition that might affect device adherence or the ability of study staff to perform skin assessments
- •Has any condition or is taking any medication that might cause excessive bruising, bleeding, or skin tearing (e.g., anti-coagulant therapy)
- •Known allergy to study device/components or ancillary devices
- •Will be unable to complete a remote visit via video chat, if required
- •Has any condition which, in the opinion of the Investigator, precludes them from participation in this study.
结局指标
主要结局
Percentage of Participants with Select Skin Conditions Observed During Securis™ Stabilization Device Use
时间窗: From placement and up tp to 24 hours after device removal
Select skin conditions include any of the following: * Blister * Rash * Skin tear * Bruising * Exudate
Rate of Securis™ Stabilization Device Securement Failure During Simulated Use
时间窗: From time of placement and up to 8 days after removal
Device securement failure is defined as any of the following: * Loose dressing * Soiled under dressing * Complete failure (complete removal) * Dislodgement of device or catheter
次要结局
- Rate of Securis™ Stabilization Device-related Adverse Events(From placement and up to 24 hours after device removal)