KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Establish the clinical safety KeySuite
研究概览
简要总结
KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that the investigators have designed for the resources, needs and challenges of low- and middle- income countries (LMICs). KeyScope is a laparoscope that plugs into a laptop computer to display images during surgery. It links to a telementoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide.
The investigators will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of intra-abdominal mass suspicious for cancer
- •body mass index (BMI) of 18-30
- •weight 20-100kg
- •biopsy necessary to determine cancer diagnosis and classify pathology
- •surgeon determine that laproscopic biopsy it technically appropriate
排除标准
- •significant comorbidities
- •previous major abdominal surgery
- •current pregnancy
研究组 & 干预措施
KeySuite
The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.
干预措施: KeySuite (Device)
结局指标
主要结局
Establish the clinical safety KeySuite
时间窗: Day of surgery
This will be determined by whether or not the procedure was able to be completed laproscopically or had to be converted to open surgery.
次要结局
- Estimated blood loss(Day of surgery)
- Surgical injuries and adverse events(Day of surgery)
- Time to complete surgery(Day of surgery)