---
title: Ultrasound Capsule Endoscopy for Esophagus Examination
nct_id: NCT05054933
overall_status: UNKNOWN
phase: NA
sponsor: Changhai Hospital
study_type: INTERVENTIONAL
primary_condition: Esophageal Diseases
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05054933.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05054933"
ct_last_update_post_date: 2021-10-01
last_seen_at: "2026-05-12T06:42:36.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Ultrasound Capsule Endoscopy for Esophagus Examination

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

**NCT ID:** [NCT05054933](https://clinicaltrials.gov/study/NCT05054933)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Changhai Hospital
- **Conditions:** Esophageal Diseases
- **Start Date:** 2021-09-26
- **Completion Date:** 2022-07-30
- **CT.gov Last Update:** 2021-10-01

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **ultrasound capsule endoscopy examination** (OTHER) — 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.

## Interventions

- **ultrasound capsule endoscopy** (OTHER) — 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 Outcomes

- **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 Outcomes

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

## Locations (1)

- Changhai Hospital, Shanghai, Shanghai Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.changhai hospital|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05054933*  
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