NCT05471401撤回不适用
GI Organ Tracking Via Balloon Applicators
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging
研究概览
简要总结
The hypothesis of this study is that an occlusion balloon catheter placed in the stomach via an oral or nasogastric route will be safe and permit tracking of the stomach during radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Scheduled to receive intra-thoracic or abdominal radiation therapy. It is not required that the stomach be in the radiation field.
- •At least 18 years of age.
- •ECOG performance status ≤ 1
- •Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
排除标准
- •Prior trauma or surgical intervention that would alter the anatomy of the upper airs (nasogastric route), esophagus or stomach.
- •Previous complete or partial surgical resection of the esophagus, stomach, or duodenum.
- •Presence of implantable devices (e.g., automatic internal cardiac defibrillator, cardiac or gastric pacemaker).
结局指标
主要结局
Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging
时间窗: Completion of follow-up for all participants (estimated to be 1 year)
次要结局
- Translation movement of stomach between CBCT scans with and without balloon insufflation(Day of procedure (Day 1))
- Number of grade grade ≥ 2 adverse events that are probably or definitely associated with the balloon inflation(Completion of follow-up (estimated to be 4 weeks))
研究者
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