A multicenter, double arm clinical study to assess the safety & efficacy of “Kardiago” a handheld portable digital 10 lead simultaneous 12 channel resting ECG device against the conventional 10 lead simultaneous 12 channel resting ECG device
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The primary endpoint of the study would be the efficacy of the IP which will be assessed by assessing the ECG results from Investigational Product and comparative product
研究概览
简要总结
The main purpose of the study is to prove efficacy of Kardiago ECG Machine. Subjects recruited are screened and recruited to participate in the study. Informed consent will be obtained before undertaking any study related procedures. The subjects will visit their designated study site on following 2 different occasions. The screening includes general check for inclusion and exclusion criteria.
If the subject satisfies the screening tests and other inclusion/ exclusion criteria, he/she is recruited into the trial. On visit two ECG test will be done in subjects using Investigational Product and then with comparative product
- Visit 1 (Screening & Randomisation/Day)
- Visit 2 (Baseline/Day 1)
PRIMARY OBJECTIVE
Primary objective of the study is to evaluate the efficacy of Kardiago ECG machine when compared with the comparative product.
SECONDARY OBJECTIVE:
Secondary objective is to assess the safety of Kardiago ECG machine, when used in human.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of age between 18 to
- •2.For whom the Investigator considers that the compliance will be correct.
- •3.Cooperating, informed of the need and duration of the study, and ready to comply with protocol procedures.
- •4.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
- •Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure, with pacemaker implants can be included.
排除标准
- •1.Known sensitivity to the investigational product.
结局指标
主要结局
The primary endpoint of the study would be the efficacy of the IP which will be assessed by assessing the ECG results from Investigational Product and comparative product
时间窗: VISIT 2
次要结局
- The Secondary end-points of this study would be safety and adverse events(VISIT 2)
研究者
Dr Jenny Madhuri Gudivada
King George Hospital