The Clinical Application of MCCES in Examination of Human Colon
The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 24, 2015
CompletedFirst Posted
Study publicly available on registry
August 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedAugust 31, 2015
August 1, 2015
1 month
August 24, 2015
August 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Migration length of anus direction
From the MCCES examination began until the capsule excreted, an expected average of 24h
The movement of mouth direction
From the MCCES examination began until the capsule excreted, an expected average of 24h
Nidus of colon
During the procedure
The level of cleanliness
From the MCCES examination began until the capsule excreted, an expected average of 24h
Procedure related complication
From the day of the examination until the follow up ended ,access up to 7 days.
Study Arms (2)
MCCES
EXPERIMENTALMagnetic -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.
Colonoscopy
ACTIVE COMPARATORColonoscopy 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or
- Patients who volunteer to the colonoscopy screening.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (3)
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.
PMID: 21087902RESULTHagel 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.
PMID: 24501724RESULTGu 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.
PMID: 27480288DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Jiang, doctor
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2015
First Posted
August 31, 2015
Study Start
August 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
August 31, 2015
Record last verified: 2015-08