Back to resultsMedical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
Primary Purpose
Capsule Endoscopy, Cancer of Stomach, Cancer of Esophagus
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Medical Consortium
Sponsored by
About this trial
This is an interventional screening trial for Capsule Endoscopy
Eligibility Criteria
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
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Medical Consortium
Arm Description
subjects involved in medical consortium for screening upper gastrointestinal canccers(MCSC)
Outcomes
Primary Outcome Measures
the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.
Secondary Outcome Measures
tthe focal lesions of upper gastrointestinal tract
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04032353
Brief Title
Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
Official Title
Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanqing Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Capsule Endoscopy, Cancer of Stomach, Cancer of Esophagus, Health Policy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medical Consortium
Arm Type
Other
Arm Description
subjects involved in medical consortium for screening upper gastrointestinal canccers(MCSC)
Intervention Type
Other
Intervention Name(s)
Medical Consortium
Intervention Description
subjects received intensive follow-up by coordinators according to the predifined protocol of MCSC
Primary Outcome Measure Information:
Title
the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
tthe focal lesions of upper gastrointestinal tract
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
adverse events
Description
safety assessment
Time Frame
12 months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqing Li, PhD, MD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PHD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
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