Ultrasound Capsule Endoscopy for Esophagus Examination

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    20
  • sponsor
    Changhai Hospital
Updated on 10 October 2021
endoscopy
capsule endoscopy
Accepts healthy volunteers

Summary

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.

Description

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 m 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.

Details
Condition Gastrointestinal Diseases and Disorders, Esophageal Disorders, Esophageal Diseases, GASTROINTESTINAL DISORDER
Treatment ultrasound capsule endoscopy
Clinical Study IdentifierNCT05054933
SponsorChanghai Hospital
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

known or suspected complex history of gastrointestinal obstruction, stenosis or fistula
dysphagia
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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