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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
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.
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.
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGManeuverability
The Maneuverability was defined as the rotation, somersault, Bird's-eye view, worm's eye view of the capsule, and completing any motion would gain 1 point, eventually ,4 point was good,2-3 point moderate,0-1point poor.
Time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h
Migration length of anus direction
Migration length of anus direction was defined as how long was the distance the capsule controlled by the Magnetic-manipulator moved from cecum to anus in 25 minutes.
Time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h
The movement of mouth direction
The movement of mouth direction was defined as if the capsule controlled by the Magnetic-manipulator could move from any point of the colon towards mouth direction.
Time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h
Nidus of colon
From date of the examination until the date of pathological diagnosis, an expected average of 7 days
Time frame: During the procedure
The level of cleanliness
The cleanliness of the colon was graded as excellent (No more than small bits of adherent feces),good(Small amount of feces or dark fluid,but not enough to interfere with the examination ),fair(Enough feces or dark fluid present to preclude a completely reliable examination),poor(large amount of fecal residue).
Time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h
Procedure related complication
Perforation, capsule retention, abdominal pain and so .etc.
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Time frame: From the day of the examination until the follow up ended ,access up to 7 days.