Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel

Zhuan Liao

Status: Unknown

Conditions: Capsule Endoscopy

Treatments: Device: DS-MCE

Study type: Interventional

Funder types: Other

Identifiers

NCT04329468

DS-MCE-UGI and SB

Details and patient eligibility

About

This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.

Full description

Magnetically controlled capsule endoscopy (MCE) has been widely used in clinical practice for upper gastrointestinal (UGI) tract and Small Bowel. However, the complete visualization of UGI tract still present challenges due to rapid transit through esophagus and duodenum, although technical improvements of MCE are helpful.

Detachable String MCE (DS-MCE) can control the movement of MCE through the string and MCE can start next examination after string detachment, which was proved to be an effective and safe method for complete viewing of the esophagus and stomach. In order to improve the duodenum visualization, endoscopist separate MCE from the string after finishing UGI examination so that can inspect the esophagus, stomach and duodenum under the string and magnetic field control.

This is a prospective, single-centered, self-controlled pilot study. Subjects with or without digestive symptoms receiving UGI endoscopy will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult patients aged 18 to 80
2. With or without gastrointestinal complaints
3. Scheduled to undergo a capsule endoscopy for both stomach and small bowel
4. Signed the informed consents before joining this study

Exclusion criteria

1. Pacemakers or electromedical devices implanted which are incompatible with magnetic field;
2. Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention;
3. Scheduled magnetic resonance imaging examination before excretion of capsule;
4. Pregnancy or suspected pregnancy;
5. Any contraindications about EGD.
6. Other circumstances that doctors consider inappropriate for the study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

DS-MCE examination

Experimental group

Description:

Subjects with or without digestive symptoms will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.

Treatment:

Device: DS-MCE