Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures
研究概览
简要总结
This study is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Patients scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure will be enrolled to this study. In addition to the standard of practice imaging using ultrasound, patients anatomical structures will be evaluated using a 3D holographic system. The patients will complete their participation in the study, at the end of the procedure. No follow-up is required and patients will continue their routine medical care following the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18
- •Patients are scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure.
排除标准
- •Denial of informed consent
- •Any contraindications to three-dimensional echocardiographic imaging.
结局指标
主要结局
HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures
时间窗: During procedure
Qualitative assessment using a Likert scale
次要结局
- HOLOSCOPE-i provides an intuitive understanding of the spatial relationship between the tool and the anatomy(During procedure)
- Satisfaction with the use of the HOLOSCOPE-i under intra-procedural conditions(During procedure)
- HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy(During procedure)