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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCCES | Experimental | 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. |
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| Colonoscopy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic-controlled capsule endoscopy system | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongxiang Gu, doctor | Contact | +86 15975625636 | Redkind@126.com | |
| Huiling Zheng, master | Contact | +86 15013113215 | bywxling@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Jiang, doctor | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21087902 | Result | Spada C, Hassan C, Ingrosso M, Repici A, Riccioni ME, Pennazio M, Pirozzi GA, Pagano N, Cesaro P, Spera G, Petruzziello L, Costamagna G. A new regimen of bowel preparation for PillCam colon capsule endoscopy: a pilot study. Dig Liver Dis. 2011 Apr;43(4):300-4. doi: 10.1016/j.dld.2010.10.005. Epub 2010 Nov 18. | |
| 24501724 | Result |
| Label | URL |
|---|---|
| Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical University | View source |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D003967 | Diarrhea |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D020685 | Colonoscopes |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Colonoscopy | Procedure |
|
|
|
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. |
| Hagel AF, Gabele E, Raithel M, Hagel WH, Albrecht H, de Rossi TM, Singer C, Schneider T, Neurath MF, Farnbacher MJ. Colon capsule endoscopy: detection of colonic polyps compared with conventional colonoscopy and visualization of extracolonic pathologies. Can J Gastroenterol Hepatol. 2014 Feb;28(2):77-82. doi: 10.1155/2014/691785. |
| 27480288 | Derived | Gu H, Zheng H, Cui X, Huang Y, Jiang B. Maneuverability and safety of a magnetic-controlled capsule endoscopy system to examine the human colon under real-time monitoring by colonoscopy: a pilot study (with video). Gastrointest Endosc. 2017 Feb;85(2):438-443. doi: 10.1016/j.gie.2016.07.053. Epub 2016 Jul 29. |
| D012817 | Signs and Symptoms, Digestive |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D020776 | Endoscopes, Gastrointestinal |
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |