The Clinical Application of MCCES in Examination of Human Colon
|ClinicalTrials.gov Identifier: NCT02536144|
Recruitment Status : Unknown
Verified August 2015 by Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : August 31, 2015
Last Update Posted : August 31, 2015
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Pain Diarrhea Hematochezia||Procedure: magnetic-controlled capsule endoscopy system Procedure: Colonoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
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
Active Comparator: Colonoscopy
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.
Other Name: colonoscope
- Maneuverability [ Time Frame: From the MCCES examination began until the capsule excreted, an expected average of 24h ]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.
- Migration length of anus direction [ Time Frame: From the MCCES examination began until the capsule excreted, an expected average of 24h ]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.
- The movement of mouth direction [ Time Frame: From the MCCES examination began until the capsule excreted, an expected average of 24h ]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.
- Nidus of colon [ Time Frame: During the procedure ]From date of the examination until the date of pathological diagnosis, an expected average of 7 days
- The level of cleanliness [ Time Frame: From the MCCES examination began until the capsule excreted, an expected average of 24h ]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).
- Procedure related complication [ Time Frame: From the day of the examination until the follow up ended ,access up to 7 days. ]Perforation, capsule retention, abdominal pain and so .etc.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536144
|Contact: Hongxiang Gu, doctor||+86 15975625636||Redkind@126.com|
|Contact: Huiling Zheng, master||+86 firstname.lastname@example.org|
|Nanfang Hospital of Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: huiling Zheng, master +86 15013113215 email@example.com|
|Principal Investigator:||Bo Jiang, doctor||Nanfang Hospital of Southern Medical University|