NCT02536144

The Clinical Application of MCCES in Examination of Human Colon

The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application.

Detailed description

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the Western world. The screening tests include flexible sigmoidoscopy, optical colonoscopy (OC), double-contrast barium enema , or CT colonography . Such screening can reduce CRC incidence and mortality but its effectiveness depends on its quality, ease of use, and patient adherence .Colon capsule endoscopy(CCE) is being actively evaluated as an emerging complementary or alternative procedure for evaluation of the colon. magnetic -controlled capsule endoscopy system is a new ingestible colon capsule robot provided by Chongqing Jinshan Science \& Technology. While Screening the colon, the capsule is drove by magnetic-manipulator outside the body, which means it can move from the cecum to anus step by step under the control of the doctor. However, there's little data report on this colon capsule robot system in clinical application. The investigators plan to conduct this prospective study to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy.

Conditions

• Abdominal Pain
• Diarrhea
• Hematochezia

Interventions

Type	Name	Description
PROCEDURE	magnetic-controlled capsule endoscopy system	1. A magnetic-controlled capsule endoscopy(MCCE) included camera,magnet,batter and high polymer material shell. 2. The MCCE would be turned to sleeping mode capturing picture at a rate of 0.5 frame per second after being swallowed. 3. While reaching cecum, the MCCE would be turned to a working mode capturing picture at a rate of 2 frame per second. 4. The MCCE would be controlled by the Magnetic-manipulator out of body to finish the motion of e rotation, somersault, Bird's-eye view, worm's eye view from cecum to anus.
PROCEDURE	Colonoscopy	1. Bowel preparation should be well done before the examination. 2. A tube with illumination and camera system would insert into colon from anus. 3. From the pictures captured by the camera ,the doctor would see the mucous of the colon.

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-08-31
• Last updated: 2015-08-31

Locations

1 site across 1 country: China