Clinical trial NCT02536144: The Clinical Application of MCCES in Examination of Human Colon
Official title: The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Pain
Diarrhea
Hematochezia
Keywords: colon capsule
magnetic
maneuverability
colonoscopy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Maneuverability
timeFrame: From the MCCES examination began until the capsule excreted, an expected average of 24h
Secondary outcomes:
measure: Migration length of anus direction
timeFrame: From the MCCES examination began until the capsule excreted, an expected average of 24h
measure: The movement of mouth direction
timeFrame: From the MCCES examination began until the capsule excreted, an expected average of 24h
measure: Nidus of colon
timeFrame: During the procedure
measure: The level of cleanliness
timeFrame: From the MCCES examination began until the capsule excreted, an expected average of 24h
measure: Procedure related complication
timeFrame: From the day of the examination until the follow up ended ,access up to 7 days.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Bo Jiang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.