Capsule EndoscopyNCT04032353
Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
A study testing Medical Consortium in people with Capsule Endoscopy and Cancer of Stomach, run by Yanqing Li at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Capsule Endoscopy, Cancer of Stomach, Cancer of Esophagus
- What is being tested?
- Medical Consortium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asymptomatic subjects undergong magnetically controlled capsule gastroscopy for health checkup in medical consotium;
- subjects able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PHD, 86-531-82169236, liyanqing@sdu.edu.cn
About this study
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.
Read the 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).
- Being tested
- Medical Consortium
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical ConsortiumOther
subjects received intensive follow-up by coordinators according to the predifined protocol of MCSC
| Study group | Role | What they receive |
|---|---|---|
| Medical Consortium | Other | subjects involved in medical consortium for screening upper gastrointestinal canccers(MCSC) Receives: Other: Medical Consortium |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.
Measured: 12 months
Secondary outcomes (1)
tthe focal lesions of upper gastrointestinal tract
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start31 Dec 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsule EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032353
- Sponsor's protocol ID
- 2019SDU-QILU-150
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
- ClinicalTrials.gov ID
- NCT04032353
- Acronym / sponsor ID
- 2019SDU-QILU-150
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Consortium | Other | Other: Medical Consortiumsubjects involved in medical consortium for screening upper gastrointestinal canccers(MCSC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asymptomatic subjects undergong magnetically controlled capsule gastroscopy for health checkup in medical consotium;
- subjects able to give informed consent
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Consortiumsubjects received intensive follow-up by coordinators according to the predifined protocol of MCSC | Other | Medical Consortium |
Primary outcome
the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.
Time frame: 12 months
1 secondary outcome
tthe focal lesions of upper gastrointestinal tract
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Consortium in people with Capsule Endoscopy and Cancer of Stomach, run by Yanqing Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, PhD, MD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.