GI Organ Tracking Via Balloon Applicators
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).
研究组 & 干预措施
Occlusion balloon catheter
-Each participant will have an embolectomy balloon that is FDA approved for peripheral and neurovasculature temporary occlusion placed by nose or mouth. Anatomical position of balloon will be verified by on-board MR or CT imaging in to assess feasibility of using a duodenal balloon in this population. Participants who are imaged on the MR treatment machine will also be imaged with 4 or 8 frame per second sagittal imaging to assess real-time stomach and balloon respiratory motion. Participants imaged on CT based imaging (i.e. Ethos/Halcyon ring gantry system) will have CBCTs acquired at timed intervals (approximately 5-10 minutes between scans). After imaging, the balloon will be deflated and removed at that time.
干预措施: Balloon-tipped catheter (Device)
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))