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临床试验/NCT05054933
NCT05054933Unknown不适用

Feasibility and Safety of Ultrasound Capsule Endoscopy for Esophagus Examination:a Pilot Study

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Success rate of esophageal examination

研究概览

简要总结

The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.

详细描述

Wireless capsule endoscopy has opened a new era by enabling remote diagnostic assessment of the gastrointestinal tract in a painless procedure. However, most commercially available devices only utilise optical imaging to examine the GI wall surface. Using this sensing modality, pathology within the GI wall cannot be detected. Micro-ultrasound (mUS) using high-frequency (>20 MHz) ultrasound can provide a means of transmural or cross-sectional image of the GI tract. Depth of imaging is approximately 10 mm with a resolution of between 40-120 μm that is sufficient to differentiate between subsurface histologic layers of the various regions of the GI tract. Ultrasound capsule endoscopy (USCE) uses a capsule equipped with mUS transducers that are capable of imaging below the GI wall surface, offering thereby a complementary sensing technique to optical imaging capsule endoscopy. In this work, a USCE device integrated with a 40 MHz ultrasonic transducer was developed to capture a full 360˚ image of the lumen. Previous animal studies of two anaesthetised Landrace pigs have demonstrated the effectiveness of the device. The reconstructed images demonstrate clear layer differentiation of the lumen wall. The tissue thicknesses measured from the B-scan images show good agreement with ex vivo images from the literature. The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.

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

入选标准

  • Participants aged 18 years or older.
  • Both inpatients and outpatients.
  • Healthy volunteers or patients with suspected esophageal disease
  • Able to provide informed consent.

排除标准

  • known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
  • known or suspected possibility of active bleeding of digestive tract.
  • Pregnancy or suspected pregnancy..
  • Patients who have participated in or are participating in other clinical trials within three months.
  • Life-threatening conditions.
  • other circumstances that doctors consider inappropriate for the study.

结局指标

主要结局

Success rate of esophageal examination

时间窗: 1 month

Assess the success rate of the clinical application of ultrasound capsule endoscopy in esophageal examination, including observe the mucosa completely and obtain ultrasound cross-sectional images in specific parts.

次要结局

  • Diagnostic accuracy(1 month)
  • Clear layer differentiation of the esophageal wall structure(1 month)
  • Safety of ultrasound capsule endoscopy examination(1 month)
  • Examination time of esophagus(1 month)
  • Discomfort scores associated with ultrasound capsule endoscopy examination(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhuan Liao

Professor

Changhai Hospital

研究点 (1)

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