The Clinical Application of MCCES in Examination of Human Colon

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Pain, Diarrhea, Hematochezia

Intervention / Treatment
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* Procedure: magnetic-controlled capsule endoscopy system
* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCCES<br>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. | Procedure: magnetic-controlled capsule endoscopy system<br>* A magnetic-controlled capsule endoscopy(MCCE) included camera,magnet,batter and high polymer material shell. The MCCE would be turned to sleeping mode capturing picture at a rate of 0.5 frame per second after being swallowed. While reaching cecum, the MCCE would be turned to a working mode capturing picture at a rate of 2 frame per second. 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.<br>|
| Active Comparator: Colonoscopy<br>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. | Procedure: Colonoscopy<br>* Bowel preparation should be well done before the examination. A tube with illumination and camera system would insert into colon from anus. From the pictures captured by the camera ,the doctor would see the mucous of the colon.<br>* Other names: colonoscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maneuverability | 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. | From the MCCES examination began until the capsule excreted, an expected average of 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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). | 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. | From the day of the examination until the follow up ended ,access up to 7 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon capsule, magnetic, maneuverability, colonoscopy