The Clinical Application of MCCES in Examination of Human Colon

NCT ID: NCT02536144

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abdominal Pain Diarrhea Hematochezia

Keywords

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colon capsule magnetic maneuverability colonoscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

magnetic-controlled capsule endoscopy system

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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colonoscope

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bo Jiang, doctor

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongxiang Gu, doctor

Role: CONTACT

Phone: +86 15975625636

Email: [email protected]

Huiling Zheng, master

Role: CONTACT

Phone: +86 15013113215

Email: [email protected]

Facility Contacts

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huiling Zheng, master

Role: primary

References

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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.

Reference Type RESULT
PMID: 21087902 (View on PubMed)

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.

Reference Type RESULT
PMID: 24501724 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27480288 (View on PubMed)

Related Links

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http://www.nfyy.com/

Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical University

Other Identifiers

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NFEK-2015-046

Identifier Type: -

Identifier Source: org_study_id