- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02536144
The Clinical Application of MCCES in Examination of Human Colon
August 26, 2015 updated by: Nanfang Hospital of Southern Medical University
The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hongxiang Gu, doctor
- Phone Number: +86 15975625636
- Email: Redkind@126.com
Study Contact Backup
- Name: huiling Zheng, master
- Phone Number: +86 15013113215
- Email: bywxling@163.com
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510515
- Recruiting
- Nanfang Hospital of Southern Medical University
-
Contact:
- huiling Zheng, master
- Phone Number: +86 15013113215
- Email: bywxling@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
From the MCCES examination began until the capsule excreted, an expected average of 24h
|
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.
|
From the MCCES examination began until the capsule excreted, an expected average of 24h
|
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
|
During the procedure
|
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).
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From the MCCES examination began until the capsule excreted, an expected average of 24h
|
Procedure related complication
Time Frame: From the day of the examination until the follow up ended ,access up to 7 days.
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Perforation, capsule retention, abdominal pain and so .etc.
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From the day of the examination until the follow up ended ,access up to 7 days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bo Jiang, doctor, Nanfang Hospital of Southern Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
August 24, 2015
First Submitted That Met QC Criteria
August 26, 2015
First Posted (Estimate)
August 31, 2015
Study Record Updates
Last Update Posted (Estimate)
August 31, 2015
Last Update Submitted That Met QC Criteria
August 26, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFEK-2015-046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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