Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Technical success of single-use gastroscopes vs reusable gastroscopes
研究概览
简要总结
The goal of this clinical trial is to investigate whether single-use gastroscopes are as good as reusable gastroscopes when used in the operation theater in all patients where gastroscopy in the operation theater is indicated. The main question it aims to answer is:
- Is the technical success and performance characteristics the same for single-use and reusable gastroscopies?
Researchers will compare single-use gastroscopes with reusable gastroscopes to see if the technical success and performance characteristics are the same in the to groups.
Participants will in the first period have gastroscopy with a single-use gastroscope. In the second period participants will have gastroscopy with a reusable gastroscope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Acute, subacute or elective gastroscopies in the operating theater
- •Age ≥ 18 years
排除标准
- 未提供
研究组 & 干预措施
Single-use gastroscope
In the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.
干预措施: Ambu aScope Gastro (Device)
Single-use gastroscope
In the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.
干预措施: Ambu aScope Gastro Large (Device)
Reusable gastroscope
In the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.
干预措施: Diagnostic gastroscopes, Olympus (Device)
Reusable gastroscope
In the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.
干预措施: Therapeutic gastroscopes, Olympus (Device)
结局指标
主要结局
Technical success of single-use gastroscopes vs reusable gastroscopes
时间窗: From admission to discharge, up to 3 months
Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines.
次要结局
- Complications(24 hours and 72 hours follow-up after procedure)
- 30th day mortality(30 days)
- Endoscopist's rating of gastroscope(Right after procedure)
- Duration of procedure(During the procedure)
- Time from procedure to discharge(From procedure to discharge, up to 3 months)
- Success of specific therapeutic procedures(During the procedure)
- Need of new gastroscopy(During admission, up to 3 months)
- Readmission(30 days after procedure)
- Sufficient ability to target the biopsy if taken(During procedure)
研究者
Camilla Kjelkvist-Born
Principal Investigator
Zealand University Hospital