NCT01062789撤回早期 1 期
Use of an Optical Breath-hold Control (OBC) System for Image-guided Interventional Radiology Procedures: A Feasibility Study
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Ability to monitor patient respiration (return of target to same anatomical position)
研究概览
简要总结
The objective or our study is to test the feasibility of a new optical-based breath-hold control (OBC) system for monitoring breath-hold levels and providing patient feedback during CT-guided biopsies of the lung and upper abdomen where respiratory motion is a problem.
详细描述
- Specific Aim #1: To further test the feasibility of the new OBC system for guiding accurate and reproducible breath-hold levels that correlate with internal target position in human volunteers. Hypothesis: The OBC system is as good as or better than the currently used IBC system with regard to accuracy and reproducibility of a reference breath-hold level.
- Specific Aim #2: To compare the use of 2 optical-based belts (wrapped around the chest and abdomen) versus 1 optical-based belt (wrapped around the chest or abdomen, depending on which region expands the most during respiration) with regard to accuracy and reproducibility of a pre-determined reference breath-hold level in a subset of patients (prone and/or obese). Hypothesis: The use of 2 optical-based belts allows increased accuracy and reproducibility of a pre-determined reference breath-hold level compared with the use of only one belt in this subset of patients.
- Specific Aim #3: To test the clinical feasibility of the new OBC system in patients undergoing CT-guided biopsy of the lung or upper abdomen where respiratory motion is a problem. Hypothesis: The OBC system is as good as or better than the currently used IBC system with regard to the accuracy and reproducibility of the reference breath-hold and ease of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for a CT-guided lung or upper abdomen biopsy (including lesions in the liver, pancreas, stomach, kidneys, adrenals, spleen, or in the peritoneum at or above the level of the kidneys) on the SMH-CT-3M scanner when either Dr. Carlson or Dr. Bender are scheduled.
- •Lesions will need to measure 3 cm or less in maximum dimension and cannot be affixed to the chest or abdominal wall.
排除标准
- •Inability to cooperate with breath-holding (including cognitive impairment, poor pulmonary function that inhibits patients from being able to hold their breath for at least 10 seconds)
- •Patients with bleeding diatheses (platelets < 50,000, International Normalized Ratio > 1.5, or activated partial thromboplastin time > twice normal)
- •Lesions that abut the pleura or abdominal wall for a distance greater than 3 cm (these lesions were assumed to be fixed in position and less likely to be affected by respiratory motion).
- •Patients with implanted medical devices (pacemakers) (this exclusion is based on the Division of Engineering Safety Review-enclosed in application)
结局指标
主要结局
Ability to monitor patient respiration (return of target to same anatomical position)
时间窗: Measured daily for each individual procedure
次要结局
- Needle Placement Time(Measured daily for each individual procedure)
研究者
研究点 (2)
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