Evaluating Reproducibility of Flow Measurements in the Superior Mesenteric Artery in Healthy Male Subjects Using Doppler Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Inter-observer reproducibility of flow measurements
研究概览
简要总结
This will be a single center, methodological study in healthy male subjects to evaluate the intra-period, inter-period and inter-observer reproducibility of flow measurements in the superior mesenteric artery, using Doppler Ultrasound.
详细描述
This will be a single center, methodological study in healthy male subjects, aged 18-50, to evaluate the intra-period, inter-period and inter-observer reproducibility of flow measurements in the superior mesenteric artery, using Doppler Ultrasound.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a male ≥18 and ≤ 50 years of age.
- •Subject is a non-smoker for at least 6 months prior to study start.
- •Subject has a body mass index between 18-28 kg/m
- •Subject is judged to be in good health on the basis of medical history and vital signs.
- •Subject understands the procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study.
- •Subject has burns, scars, flaps or grafts on the abdomen which, in the investigator's opinion, may interfere with the study assessments.
- •Subject has an anatomical anomaly of the SMA as evaluated with DUS during screening which, in the investigator's opinion, may interfere with the study assessments.
- •Subject currently uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study. Subject has taken 7 days prior to the start of the study any prescription or non-prescription drugs which, in the investigator's opinion, might confound the results of the study.
- •Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit or has a history of drug (including alcohol) abuse.
- •Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, ...) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study.
- •Subject has any of the following vital sign measurements at screening: Heart Rate <40 or >100 beats/min, Diastolic Blood Pressure <50 or >90 mmHg, Systolic Blood Pressure <90 or >140 mmHg.
- •Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks.
- •Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study.
结局指标
主要结局
Inter-observer reproducibility of flow measurements
时间窗: Interval of 15 minutes between two measurements during study visit 2
Reproducibility of flow measurements performed during study visit 2 by two different observers.
Intra-period reproducibility of flow measurements
时间窗: Interval of 30 minutes between two measurements during study visit 2
Reproducibility of flow measurements performed during study visit 2 by the same observer.
Inter-period reproducibility of flow measurements
时间窗: Interval of at least 3 days between both study visits
Reproducibility (i.e. assessing changes) of flow measurements performed during two separate study visits by the same observer
次要结局
未报告次要终点