The Clinical Application of MCCES in Examination of Human Colon

Diarrhea Clinical Trial

Official title:

The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02536144
• Other study ID #: NFEK-2015-046
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2015
• Last updated: August 26, 2015
• Start date: August 2015
• Est. completion date: September 2015

Study information

• Verified date: August 2015
• Source: Nanfang Hospital of Southern Medical University
• Contact: Hongxiang Gu, doctor
• Phone: +86 15975625636
• Email: Redkind[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Pain
• Diarrhea
• Hematochezia

Intervention

Procedure:
• magnetic-controlled capsule endoscopy system
A magnetic-controlled capsule endoscopy(MCCE) included camera,magnet,batter and high polymer material shell. The MCCE would be turned to sleeping mode capturing picture at a rate of 0.5 frame per second after being swallowed. While reaching cecum, the MCCE would be turned to a working mode capturing picture at a rate of 2 frame per second. 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
Bowel preparation should be well done before the examination. A tube with illumination and camera system would insert into colon from anus. From the pictures captured by the camera ,the doctor would see the mucous of the colon.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Hagel AF, Gäbele 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. — View 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):3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Migration length of anus direction	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	No
Secondary	The movement of mouth direction	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	No
Secondary	Nidus of colon	From date of the examination until the date of pathological diagnosis, an expected average of 7 days	During the procedure	No
Secondary	The level of cleanliness	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).	From the MCCES examination began until the capsule excreted, an expected average of 24h	No
Secondary	Procedure related complication	Perforation, capsule retention, abdominal pain and so .etc.	From the day of the examination until the follow up ended ,access up to 7 days.	Yes

External Links

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