Medical Consortium for Screening Upper Gastrointestinal C... | NCT04032353

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

NCT04032353

Sponsor

Yanqing Li

Status

Unknown status

Last Update Posted

Jul 25, 2019Actual

Enrollment

10,000Estimated

Phase

Not Applicable

Conditions

Capsule Endoscopy
Cancer of Stomach
Cancer of Esophagus
Health Policy

Interventions

Medical Consortium

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2018Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Mar 1, 2020Estimated

First Submitted Date

Jul 23, 2019

First Submission Date that Met QC Criteria

Jul 24, 2019

First Posted Date

Jul 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2019

Last Update Posted Date

Jul 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical Consortium	Other	subjects involved in medical consortium for screening upper gastrointestinal canccers(MCSC)	Other: Medical Consortium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical Consortium	Other	subjects received intensive follow-up by coordinators according to the predifined protocol of MCSC	Medical Consortium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.		12 months

Secondary Outcomes

Measure	Description	Time Frame
tthe focal lesions of upper gastrointestinal tract		12 months

Other Outcomes

Measure	Description	Time Frame
adverse events	safety assessment	12 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanqing Li, PhD, MD	Contact	86-531-82169236		liyanqing@sdu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University	Recruiting	Jinan	Shandong	250012	China

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided