Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Constant Pressure Skin Disk (CPSD) durability
研究概览
简要总结
Researchers are gathering information on one specific part of a feeding tube, known as the adjustable skin disk. Researchers are trying to see if a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), can safely and effectively support adequate healing, and reduced complication rates.
详细描述
During the procedure of placing a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube), the gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk (CPSD) by sliding the former off and the latter on to the feeding tube.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 22 years
- •Undergoing PEG tube or PEJ tube placement
排除标准
- •History of tobacco or illegal drug use in the past year
- •History of an enteral tube
- •History of gastric surgery (bariatric surgery, Nissen fundoplication, etc.)
研究组 & 干预措施
Gastrostomy Tube
Non-hospitalized outpatients undergoing placement of a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube) will receive the usual Standards of Care related to the placement of a GIG or GIJ tube and the Constant Pressure Skin Disk.
干预措施: Constant Pressure Skin Disk (Device)
结局指标
主要结局
Constant Pressure Skin Disk (CPSD) durability
时间窗: 180 days
Number of devices that remain intact
次要结局
- Adverse Events(180 days)
研究者
Manpreet S. Mundi
Principal Investigator
Mayo Clinic