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The Clinical Application of MCCES in Examination of Human Colon

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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
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Diarrhea Hematochezia Procedure: magnetic-controlled capsule endoscopy system Procedure: Colonoscopy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MCCES
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
  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.

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.
Procedure: Colonoscopy
  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.
Other Name: colonoscope




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536144


Contacts
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Contact: Hongxiang Gu, doctor +86 15975625636 Redkind@126.com
Contact: Huiling Zheng, master +86 15013113215 bywxling@163.com

Locations
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China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: huiling Zheng, master    +86 15013113215    bywxling@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Bo Jiang, doctor Nanfang Hospital of Southern Medical University
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02536144    
Other Study ID Numbers: NFEK-2015-046
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015
Keywords provided by Nanfang Hospital of Southern Medical University:
colon capsule
magnetic
maneuverability
colonoscopy
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Diarrhea
Abdominal Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes