Magnet Controlled Capsule EndoscopyNCT04278196
Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.
An observational study of Magnet Controlled Capsule Endoscopy, run by Shandong University at 1 site in China.
Trial summary
During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnet Controlled Capsule Endoscopy
- What is being tested?
- AI-Box
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Nov 2020
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who acccept the magnet controlled capsule endoscopy with the help of "AI-box"will be enrolled.
Who may be able to join
- patients between 18 and75
- patients who can sign informed consent
Who cannot join
- patients who are unsuitable to accept the check
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.
Read the detailed description
We developed a new artificial intelligence for quality improving during the operation of magnet controlled endoscopy. The AI can help operators screen every part of gastric and then evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than that ,we compared the performancce of AI with experts.
- Conditions
- Magnet Controlled Capsule Endoscopy
- Being tested
- AI-Box
- Keywords
- Artificial intelligence, Magnet controlled capsule endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-BoxOther
AI-box is a system fixed adjacent to magnet controlled capsule endoscopy. Patients who accept the check of magnet controlled capsule endoscopywill be enrolled .
What is being measured
The primary outcome is the main question the study is designed to answer.
The integrity of the magnet controlled capsule endoscopy
The performance of the operator developing the MCE in screen the gastric without omissions
Measured: 2 months
The visibilty of the gastric
Evaluating the performance of AI to recognize the visibility of gastric mucosa
Measured: 2 months
The time of operation in gastric
Calculating the time of the magnet controlled capsule endoscapy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278196
- Sponsor's protocol ID
- 2020SDU-QILU-24
- Status last verified
- May 2021
- First submitted
- 19 Feb 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.
- ClinicalTrials.gov ID
- NCT04278196
- Acronym / sponsor ID
- 2020SDU-QILU-24
- Conditions
- Magnet Controlled Capsule Endoscopy
- Keywords
- Artificial intelligence, Magnet controlled capsule endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 20 Feb 2020 (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.
During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.
Detailed description
We developed a new artificial intelligence for quality improving during the operation of magnet controlled endoscopy. The AI can help operators screen every part of gastric and then evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than that ,we compared the performancce of AI with experts.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who acccept the magnet controlled capsule endoscopy with the help of "AI-box"will be enrolled.
Key inclusion criteria (2 listed)
- patients between 18 and75
- patients who can sign informed consent
Key exclusion criteria (1 listed)
- patients who are unsuitable to accept the check
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-BoxAI-box is a system fixed adjacent to magnet controlled capsule endoscopy. Patients who accept the check of magnet controlled capsule endoscopywill be enrolled . | Other | – |
Primary outcome
The integrity of the magnet controlled capsule endoscopy
Time frame: 2 months
The performance of the operator developing the MCE in screen the gastric without omissions
The visibilty of the gastric
Time frame: 2 months
Evaluating the performance of AI to recognize the visibility of gastric mucosa
The time of operation in gastric
Time frame: 2 months
Calculating the time of the magnet controlled capsule endoscapy
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 11 May 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 1 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 11 May 2021. 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?
The integrity of the magnet controlled capsule endoscopy (time frame: 2 months). The study lists 3 primary outcomes in all. 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 11 May 2021.