The Clinical Application of MCCES in Examination of Human Colon

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Hematochezia; Diarrhea; Abdominal Pain

Treatments: Procedure: Colonoscopy; Procedure: magnetic-controlled capsule endoscopy system

Study type: Interventional

Funder types: Other

Identifiers

NCT02536144

NFEK-2015-046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or
• Patients who volunteer to the colonoscopy screening.

Exclusion criteria

• Dysphagia or swallowing disorder,
• Congestive heart failure,
• Renal insufficiency,
• Prior major abdominal surgery of the gastrointestinal tract,
• Known or suspected bowel obstruction,
• Presence of a cardiac pacemaker or other implanted electromedical devices,
• Allergy or contraindication to the medications used in the study.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

MCCES

Experimental group

Description:

Magnetic -controlled capsule endoscopy system (MCCES) is a robot system that the capsule would be swallowed to observe the mucosa of the human alimentary canal especially the colon under the control of the magnetic-manipulator.

Treatment:

Procedure: magnetic-controlled capsule endoscopy system

Colonoscopy

Active Comparator group

Description:

Colonoscopy has now been in use for many years to visualize and diagnose abnormalities of the colon and it is the gold standard for detecting colorectal lesions.In this study,the additional utility of the colonoscopy is to monitor the movement of the Magnetic -controlled capsule endoscopy.

Treatment:

Procedure: Colonoscopy