Ultrasound Capsule Endoscopy for Esophagus Examination

Not Applicable

• Conditions: Esophageal Diseases
• Interventions: Other: ultrasound capsule endoscopy

• Registration Number: NCT05054933
• Lead Sponsor: Changhai Hospital

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.

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 Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-09-19
• Study First Posted: 2021-09-23
• Study Start: 2021-09-26
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultrasound capsule endoscopy examination	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.

Primary Outcome Measures

Name	Time	Method
Success rate of esophageal examination	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

Name	Time	Method
Diagnostic accuracy	1 month	The diagnostic accordance rate, sensitivity and specificity of lesions detected by ultrasound capsule endoscopy compared with conventional endoscopic ultrasound examination.
Clear layer differentiation of the esophageal wall structure	1 month	Assess the success rate of clear layer differentiation of the esophageal wall structure by ultrasound capsule endoscopy examination
Safety of ultrasound capsule endoscopy examination	1 month	The presence of any adverse events during ultrasound capsule endoscopy examination procedure will be recorded.
Examination time of esophagus	1 month	Record the time taken to finish examination of esophagus under ultrasound capsule endoscopy.
Discomfort scores associated with ultrasound capsule endoscopy examination	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.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China