INJ-INAR-01 Use of BIP-Needles in Rheumatologic Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- True Positive Detection of Synovial Fluid Marked in Case Report Form
研究概览
简要总结
The study focuses on needle guidance in rheumatologic operations - glucocorticoid injections inside joint capsules specifically. The main purpose of the study is to assess and validate the clinical feasibility and performance of Bioimpedance Probe (BIP) Needles and assess the benefits, drawbacks and risks related to use of the BIP Needles.
详细描述
Clinical device investigation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Adult patients having an inflammatory rheumatic disease requiring an intra-articular glucocorticoid injection.
排除标准
- •Exclusion criteria are the same as generally for intra-articular glucocorticoid injections (e.g. bacterial infection or recent surgical operation relating the joint).
- •In addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion.
- •In addition pregnant women are excluded
研究组 & 干预措施
BIP Needle
Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.
干预措施: Injeq Bioimpedance Probe (BIP) Needle (Device)
结局指标
主要结局
True Positive Detection of Synovial Fluid Marked in Case Report Form
时间窗: During intra-articular injection
Measurement device indicates with a sound and visual feedback when needle is in contact with synovial fluid. Physician verifies the location with ultrasound imaging, aspiration of synovial fluid and/or lack of resistance in glucocorticoid injection. Even if the device does not detect the synovial fluid, physician performs the injection when needed. Physician marks to the case report form whether the device provided detections during the puncture and were the detections true or false detections.
次要结局
未报告次要终点