NCT01590368Unknown3 期
A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 主要终点
- Product Performance : Remain in place
研究概览
简要总结
It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent
- •Be a healthy volunteer and be over 18 years of age
- •Willing to attend two scheduled visits for application and removal of the device and adverse event review
- •Have healthy unbroken skin
排除标准
- •Subjects with a history of sensitivity to any one of the components of the device being studied
- •Subjects who have a history of skin related disorders to the chest.
- •Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes
- •Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
- •Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace
结局指标
主要结局
Product Performance : Remain in place
时间窗: 30 minutes
Ability to remain in place for a duration of 30 minutes (as per intended use)
Product Performance: Perform
时间窗: 30 minutes
Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use.
次要结局
- Safety: Adverse Events(2 days)
- Skin Rating(2 days)
研究者
相似试验
已完成
不适用
Evaluation of the effect of tissue adhesive and suture on the postoperative paiIRCT20210306050604N1Yazd University of Medical Sciences18
进行中（未招募）
不适用
Efficiency of Different Modes of Universal AdhesiveAdhesionDental CariesNCT04271150Hacettepe University25
已完成
不适用
An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device)Healthy Volunteer StudyNCT04836572SQ Innovation, Inc.60
已完成
不适用
Clinical assessment of using two types of adhesive (PQ1, Prompt-l-pop) on the success rate of fissure sealant with and without saliva contaminatiothe effect of using bonding on fissure sealant success rate.-IRCT138903184123N1Khorasgan branch Islamic Azad University60
已完成
不适用
Observational study on clinical performance of resin composite restorations in non-carious cervical lesionson-carious cervical lesionsJPRN-UMIN000028745agasaki University35