Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Proportion of patients with pre-specified adverse events
研究概览
简要总结
This is an investigator led prospective open label investigation, performed at three clinics in Sweden, comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling method endoscopic ultrasound fine needle aspiration/biopsy. Assessment of safety is the primary objective and performance is the secondary objective.
详细描述
The investigation will include 20 patients with lesions and suspected tumors in the stomach, esophagus or duodenum (upper small intestine). The investigation will consist of one visit with an endoscopic examination with sampling of an observed lesion or suspected tumor. Six biopsies will be collected from each patient, three consecutive samples using the Endodrill Model X instrument and three consecutive samples using the standard fine needle. The order of instruments to be used will be randomly assigned. The patient will be under observation for 2 hours after the procedure. Telephone follow-up will be performed 1 and 7 days after the examination. Visual confirmation of the biopsies size will be recorded at the examination. If the samples verify a tumor or not will be evaluated at Day 14 when the pathology report is concluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The order of the instruments to be used is blinded to the endoscopist until after the tumor has been visualized to avoid and minimize the influence of the choice of instrument of where the sample is taken. Closed envelopes prepared according to a randomization list stratified by site are available at each site. The envelope is opened by an assistant and not shown to the examiner until the tumor has been visualized.
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
- •Adults at least 18 years of age at the day of inclusion
- •Signed informed consent
- •Submucosal tumor of the upper gastrointestinal tract with tumor size ≥ 10 mm, well localized by the endoscopic examination
排除标准
- •Suspicion of vascular tumor (e.g. pulsating tumor)
- •Ongoing treatment with anticoagulants (e.g. Warfarin)
- •Ongoing treatment with immunosuppressive drugs
- •Pregnancy
研究组 & 干预措施
Endodrill Model X
Three consecutive samples will be taken using the Endodrill Model X instrument.
干预措施: Endodrill Model X (Device)
Endoscopic ultrasound guided fine-needle aspiration/biopsy
Three consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy.
干预措施: Fine-needle aspiration/biopsy (Device)
结局指标
主要结局
Proportion of patients with pre-specified adverse events
时间窗: 10 days
Proportion of patients with one or more of the following: 1) non-intentional perforation of the sampled organ, 2) bleeding requiring open surgical intervention or treatment at an intensive care unit, 3) non-planned hospitalization for observation AND where the patient is not fully recovered within 10 days after the endoscopic examination
次要结局
- Amount of visible biopsy material over or under 5 mm at endoscopy examination(Day 0 (day of biopsy))