Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy

Cancer of Stomach Clinical Trial

Official title:

Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04032353
• Other study ID #: 2019SDU-QILU-150
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2019
• Source: Shandong University
• Contact: Yanqing Li, PhD, MD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study was to demonstrate the efficacy and feasibility of the medical consortium for screening upper gastrointestinal cancers with magnetically controlled capsule gastroscopy.

Description:

In this study, the investigators designed a propective cohort study to evaluate the the efficacy and feasibility of medical consortium for screening upper gastrointestinal cancers (MCSC) with magnetically controlled capsule gastroscopy (MCCG).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: March 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• asymptomatic subjects undergong magnetically controlled capsule gastroscopy for health checkup in medical consotium;

• subjects able to give informed consent

Exclusion Criteria:

• suspected or known intestinal stenosis, obstruction, or fistula;

• inoperability of refusal to accept any abdominal surgery;

• dysphagia or gastric paralysis;

• previous history of gastrointestinal disease;

• with pacemaker, implanted-cardiac defibrillator or other implanted electromedical devices;

• need for standard magnetic resonance imaging examination within seven days after swallowing the MCCG, unless the capsule is confirmed to have been excreted;

• other factors that are not suitable for inclusion evaluated by medical stuff

Related Conditions & MeSH terms

• Cancer of Esophagus
• Cancer of Stomach
• Capsule Endoscopy
• Esophageal Neoplasms
• Gastrointestinal Neoplasms
• Health Policy
• Stomach Neoplasms

Intervention

Other:
• Medical Consortium
subjects received intensive follow-up by coordinators according to the predifined protocol of MCSC

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yanqing Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events	safety assessment	12 months
Primary	the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.		12 months
Secondary	tthe focal lesions of upper gastrointestinal tract		12 months