NCT04329468

Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel

Detachable String Magnetically Controlled Capsule Endoscopy for Complete Examination of Upper Gastrointestinal Tract and Small Bowel

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Zhuan Liao · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Capsule Endoscopy

Interventions

Type	Name	Description
DEVICE	DS-MCE	The subjects swallowed the MCE to investigate the esophagus repeatedly by pulling up or down the string. After completion of the esophageal examination, MCE reached the stomach and was lifted away from the posterior wall, rotated if necessary and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination, the capsule would enter the duodenum due to peristalsis when the pylorus opened. Then DS-MCE tried to inspect the duodenum repeatedly under the string and magnetic field control, including view of major papilla in the descending part of duodenum and retrograde view of pylorus in duodenal bulb with a "360-degree automatic scanning" mode. After completion of the duodenum examination, the capsule started to view the small bowel.

Timeline

• Start date: 2020-03-10
• Primary completion: 2020-08-20
• Completion: 2020-09-20
• First posted: 2020-04-01
• Last updated: 2020-07-21

Locations

1 site across 1 country: China