NCT04032353

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 23, 2019

Last Update Submit

July 24, 2019

Conditions

Capsule EndoscopyCancer of StomachCancer of EsophagusHealth Policy

Outcome Measures

Primary Outcomes (1)

  • the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.

    12 months

Secondary Outcomes (1)

  • tthe focal lesions of upper gastrointestinal tract

    12 months

Other Outcomes (1)

  • adverse events

    12 months

Study Arms (1)

Medical Consortium

OTHER

subjects involved in medical consortium for screening upper gastrointestinal canccers(MCSC)

Other: Medical Consortium

Interventions

Medical ConsortiumOTHER

subjects received intensive follow-up by coordinators according to the predifined protocol of MCSC

Medical Consortium

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asymptomatic subjects undergong magnetically controlled capsule gastroscopy for health checkup in medical consotium;
  • subjects able to give informed consent

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Central Study Contacts

Yanqing Li, PhD, MD

CONTACT

86-531-82169236liyanqing@sdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice president of Qilu Hospital

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 25, 2019

Study Start

December 31, 2018

Primary Completion

December 31, 2019

Study Completion

March 1, 2020

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

CN(1)