Magnet Controlled Capsule EndoscopyNCT04954677
A Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy
A study testing AI-box in people with Magnet Controlled Capsule Endoscopy, run by Shandong University at 1 site in China.
Trial summary
With the rapid development of artificial intelligence technology, more and more deep learning technology has been applied to medicine. Our research is to develop a set of quality control system for magnetic capsule gastroscope using deep learning technology, and conduct a randomized controlled trial to verify its… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Magnet Controlled Capsule Endoscopy
- What is being tested?
- AI-box
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2021to 4 Aug 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients aged 18-75 years old who underwent MCCG examination in Qilu Hospital of Shandong University, Shandong Provincial Hospital affilated to Shandong First Medican University, and the Binzhou Medical University Hospital.
Who cannot join
- People who are allergic to the ingredients prepared in the stomach before examination;
- Patients with astrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
- Patients with esophageal and gastric tumor diseases that are undergoing active surgical treatment;
- Contraindications to the MCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc; presence of gastrointestinal obstruction symptoms such as pain or dysphagia;
- Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
- Inoperative conditions or refusal to undergo abdominal surgery if required (ie, if the capsule will not pass and cannot be removed by endoscopy);
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- A cardiac pacemaker is installed in the body, except when the pacemaker is a new MRE-compatible product;
- Electronic devices such as cochlear implant, magnetic metal drug infusion pump, nerve stimulator and magnetic metal foreign body are implanted in vivo;
- Planned MRI examination before capsule endoscopy discharge;
- Pregnant women;
- Patients with deglutition disorders or gastric emptizing disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial of AI-box , a Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy.
With the rapid development of artificial intelligence technology, more and more deep learning technology has been applied to medicine. Our research is to develop a set of quality control system for magnetic capsule gastroscope using deep learning technology, and conduct a randomized controlled trial to verify its practical efficiency.
Read the detailed description
The accuracy of magnetic controlled capsule endoscopy(MCCE) in the diagnosis of stomach lesions is highly consistent with the traditional electronic gastroscopy. It has become a new comfortable and safe form for screening and It is also the beneficial complementarity of the traditional electronic gastroscope. To ensure the medical quality of magnetic controlled capsule endoscopy system, Based on Artificial Intelligence Deep Learning Technology ,investigators developed the Magnetic-controlled Capsule Endoscopic Assisted Quality Control System(AI-box).Randomized controlled trials will be conducted on prospective subjects to verify the quality control efficiency.
- Conditions
- Magnet Controlled Capsule Endoscopy
- Being tested
- AI-box
- Keywords
- Artificial intelligence, Deep learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-boxOther
Automatic quality-control system（AI-box）could real-time measure endoscopic inspection completeness, evaluate gastric cleanliness.
| Study group | Role | What they receive |
|---|---|---|
| Participates being subjected to capsule endoscopy (AI-box assistant) | Experimental | In this group ,Participates will be subjected to magnetically controlled capsule gastroscopy with AI-box assistant. Receives: Other: AI-box |
| Participates being subjected to capsule endoscopy | No intervention | In this group ,Participates will be subjected to magnetically controlled capsule gastroscopy without AI-box assistant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean inspection completeness
After the inspection，investigators will review the whole process of inspection and record the sites observed as well as unobserved sites，then calculate the inspection completeness（number of observed sites in each patient/10）besides the the blind spot rate(number of unobserved sites in each patient/10 ) per procedure in control group and AI-assisted group.
Measured: 4 months
Secondary outcomes (1)
Cleanliness judgement consistency between expert and AI-box
After the inspection，investigators will review the whole process of inspection and make a judgement of cleanliness of different sites of gastric then compared with the cleanliness judgement of AI-box. So at last investigators will calculate the accuracy of the AI result.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start27 Aug 2021
- Primary completion28 Jul 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnet Controlled 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Ancon Technologies Ltd, Shandong Provincial Hospital, Binzhou Medical University
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954677
- Sponsor's protocol ID
- 2021-SDU-QILU-087
- Status last verified
- Jan 2025
- First submitted
- 18 Jun 2021
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, Shen D, Zhao Y, Xing J, Liu J, Zhou R, Yang C, Liu C, Ma X, Ge J, Zhang H, Yuan W, Zhang H, Ma Y, Hu P, Zuo X, Li Y, Li Z. Impact of a real-time automatic quality control system for magnetically controlled capsule gastroscopy: a multicenter randomized controlled trial. BMC Med. 2026 May 2;24(1):369. doi: 10.1186/s12916-026-04901-0.
PubMed 42069608
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of AI-box , a Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy.
- ClinicalTrials.gov ID
- NCT04954677
- Acronym / sponsor ID
- 2021-SDU-QILU-087
- Conditions
- Magnet Controlled Capsule Endoscopy
- Keywords
- Artificial intelligence, Deep learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Ancon Technologies Ltd, Shandong Provincial Hospital, Binzhou Medical University
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 8 Jul 2021 (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.
With the rapid development of artificial intelligence technology, more and more deep learning technology has been applied to medicine. Our research is to develop a set of quality control system for magnetic capsule gastroscope using deep learning technology, and conduct a randomized controlled trial to verify its practical efficiency.
Detailed description
The accuracy of magnetic controlled capsule endoscopy(MCCE) in the diagnosis of stomach lesions is highly consistent with the traditional electronic gastroscopy. It has become a new comfortable and safe form for screening and It is also the beneficial complementarity of the traditional electronic gastroscope. To ensure the medical quality of magnetic controlled capsule endoscopy system, Based on Artificial Intelligence Deep Learning Technology ,investigators developed the Magnetic-controlled Capsule Endoscopic Assisted Quality Control System(AI-box).Randomized controlled trials will be conducted on prospective subjects to verify the quality control efficiency.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participates being subjected to capsule endoscopy (AI-box assistant) | Experimental | Other: AI-boxIn this group ,Participates will be subjected to magnetically controlled capsule gastroscopy with AI-box assistant. |
| Participates being subjected to capsule endoscopy | No intervention | –In this group ,Participates will be subjected to magnetically controlled capsule gastroscopy without AI-box assistant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients aged 18-75 years old who underwent MCCG examination in Qilu Hospital of Shandong University, Shandong Provincial Hospital affilated to Shandong First Medican University, and the Binzhou Medical University Hospital.
Key exclusion criteria (11 listed)
- People who are allergic to the ingredients prepared in the stomach before examination;
- Patients with astrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
- Patients with esophageal and gastric tumor diseases that are undergoing active surgical treatment;
- Contraindications to the MCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc; presence of gastrointestinal obstruction symptoms such as pain or dysphagia;
- Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
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 |
|---|---|---|
| AI-boxAutomatic quality-control system（AI-box）could real-time measure endoscopic inspection completeness, evaluate gastric cleanliness. | Other | Participates being subjected to capsule endoscopy (AI-box assistant) |
Primary outcome
Mean inspection completeness
Time frame: 4 months
After the inspection，investigators will review the whole process of inspection and record the sites observed as well as unobserved sites，then calculate the inspection completeness（number of observed sites in each patient/10）besides the the blind spot rate(number of unobserved sites in each patient/10 ) per procedure in control group and AI-assisted group.
1 secondary outcome
Cleanliness judgement consistency between expert and AI-box
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Derived from this study: PubMed 42069608Wang X, Shen D, Zhao Y, Xing J, Liu J, Zhou R, Yang C, Liu C, Ma X, Ge J, Zhang H, Yuan W, Zhang H, Ma Y, Hu P, Zuo X, Li Y, Li Z. Impact of a real-time automatic quality control system for magnetically controlled capsule gastroscopy: a multicenter randomized controlled trial. BMC Med. 2026 May 2;24(1):369. doi: 10.1186/s12916-026-04901-0.
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.
Yanqing Li, PhD study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-box in people with Magnet Controlled Capsule Endoscopy, run by Shandong University 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 3 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean inspection completeness (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04954677, which also lists 1 linked publication.
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 3 Jan 2025.