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Ultrasound Capsule Endoscopy for Esophagus Examination

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ClinicalTrials.gov Identifier: NCT05054933
Recruitment Status : Recruiting
First Posted : September 23, 2021
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Diseases Other: ultrasound capsule endoscopy Not Applicable

Detailed 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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Safety of Ultrasound Capsule Endoscopy for Esophagus Examination：a Pilot Study
Actual Study Start Date : September 26, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
ultrasound capsule endoscopy examination
Healthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks.
 Other: ultrasound capsule endoscopy
Healthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Success rate of esophageal examination [ Time Frame: 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.


Secondary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 1 month ]
    The diagnostic accordance rate, sensitivity and specificity of lesions detected by ultrasound capsule endoscopy compared with conventional endoscopic ultrasound examination.

  2. Clear layer differentiation of the esophageal wall structure [ Time Frame: 1 month ]
    Assess the success rate of clear layer differentiation of the esophageal wall structure by ultrasound capsule endoscopy examination

  3. Safety of ultrasound capsule endoscopy examination [ Time Frame: 1 month ]
    The presence of any adverse events during ultrasound capsule endoscopy examination procedure will be recorded.

  4. Examination time of esophagus [ Time Frame: 1 month ]
    Record the time taken to finish examination of esophagus under ultrasound capsule endoscopy.

  5. Discomfort scores associated with ultrasound capsule endoscopy examination [ Time Frame: 1 month ]
    Assess the discomfort score caused by the string, swallowing the ultrasound capsule, pulling the capsule up or down, and pulling the capsule out. A visual analogue scale ranging from 0 (easy with no nausea) to 10 (very difficult or with sever nausea) was used to evaluate the degree of difficulty of the discomfort score caused by the string.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
  2. dysphagia.
  3. known or suspected possibility of active bleeding of digestive tract.
  4. Pregnancy or suspected pregnancy..
  5. Patients who have participated in or are participating in other clinical trials within three months.
  6. Life-threatening conditions.
  7. other circumstances that doctors consider inappropriate for the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054933


Contacts
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Contact: Zhuan Liao, Professor (81)02131161024 zhuanleo@126.com
Contact: Xi Jiang, PhD 81-13127952352 jiangxi_stella@126.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Zhuan Liao    +86-21-31161004    liaozhuan@smmu.edu.cn   
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Zhuan Liao, Professor Changhai Hospital,Shanghai,China
More Information
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Publications:

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Responsible Party: Zhuan Liao, Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT05054933    
Other Study ID Numbers: Ultrasound CE
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Liao, Changhai Hospital:
capsule endoscopy; ultrasound
Additional relevant MeSH terms:
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Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases