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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-ODB-15007598
Date of registration: 2015-12-17
Prospective Registration: Yes
Primary sponsor: Southern Medical University, Nanfang Hospital, Department of Gastroenterology
Public title: The effectiveness of NaviCam magnetron capsule endoscopy in gastric lesions follow-up crowd: A multi-center, self-controlled clinical trial
Scientific title: The effectiveness of NaviCam magnetron capsule endoscopy in gastric lesions follow-up crowd: A multi-center, self-controlled clinical trial
Date of first enrolment: 2015-12-17
Target sample size: Group A:250;Group B:250;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=12775
Study type:  Observational study
Study design:  historical control  
Phase:  Diagnostic New Technique Clincal Study
Countries of recruitment
China
Contacts
Name: Yue Li   
Address:  1838 North Guangzhou Avenue, Guangzhou
Telephone: +86 15975537291
Email: lwmilan@126.com
Affiliation:  Southern Medical University, Nanfang Hospital, Department of Gastroenterology
Name: Side Liu   
Address:  1838 North Guangzhou Avenue, Guangzhou
Telephone: +86 15975537291
Email: liuside2011@163.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. 18-70 years old, male or female;
2. has a clear stomach lesions (atrophic gastritis, gastric ulcer, gastric polyps, gastric cancer, gastric stromal tumors, etc.),have received medical treatment or therapy under endoscopy (APC, EMR, ESD, ligation, etc.), need regular follow-up, and these lesions need to have gastroscopy report;
3. the patient agreed to participate in this experiment, and voluntary signed the informed consent.

Exclusion criteria: 1. this follow-up required therapeutic endoscopy (clearly have the stomach, esophageal mucosal lesions within the required endoscopic treatment);
2. known or suspected gastrointestinal obstruction, strictures and fistula, or suffering from inflammatory bowel disease (such as Crohn's disease and ulcerative colitis), gastrointestinal dysfunction, patients with acute gastrointestinal during the current test;
3. no surgical conditions or refuse to accept any abdominal surgery (once the residence of the capsule will not be removed by surgery);
4. heart pacemakers or other electronic equipment by magnetic interference implant;
5. can not tolerate ordinary endoscopy, the patient required painless gastroscopy;
6. the patient who has been involved in this study;
7. swallowing disorders or pregnant women.


Age minimum: 18
Age maximum: 70
Gender: Both
Health Condition(s) or Problem(s) studied
Gastric mucosal lesions
Intervention(s)
Group A:first magnetron capsule endoscopy then electronic gastroscopy;Group B:first electronic gastroscopy thenmagnetron capsule endoscopy ;
Primary Outcome(s)
Past lesion detection rate;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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