Capsule EndoscopyNCT04933643
Analysis of Influencing Factors of Gastric Preparation Quality for MCCG
An observational study of Capsule Endoscopy, run by Shandong University at 1 site in China.
Trial summary
The invention of magnetically controlled capsule gastroscopy makes the movement of capsule endoscope in the body controllable. Endoscopic doctors can adjust the angle of capsule observation to examine gastric mucosa according to the need of examination. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Capsule Endoscopy
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2021to Mar 2023
- How long will I take part?
- 2 Weeks
- 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: patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender
Who may be able to join
- patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender
- sign informed consent form
Who cannot join
- dysphagia, known or suspected gastrointestinal obstruction、stricture and fistula
- patients with severe somatic diseases unable to complete examination
- known active upper gastrointestinal bleeding
- previous history of upper digestive tract or abdominal surgery to change
- gastrointestinal anatomy
- patients with cardiac pacemakers or implanted with other electronic medical
Show all 9Show fewer
- instruments and magnetic metal foreign bodies
- pregnant women
- claustrophobia or other mental disorders uncontrollable
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. MD., 18678827666, liyanqing@sdu.edu.cn
About this study
Official title: Analysis of Influencing Factors of Gastric Preparation Quality for Magnetically Controlled Capsule Gastroscopy
The invention of magnetically controlled capsule gastroscopy makes the movement of capsule endoscope in the body controllable. Endoscopic doctors can adjust the angle of capsule observation to examine gastric mucosa according to the need of examination. However, The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy. it will reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis. The purpose of this study is to explore the factors affecting the quality of gastroscopy gastric environmental preparation of magnetically capsule.
Read the detailed description
Magnetically controlled capsule endoscopy is different from ordinary electronic gastroenteroscopy, it can not fill and clean the gastric cavity by water injection. The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy, reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis, so the quality of MCCG gastric environmental preparation is an important factor limiting the accuracy of diagnosis of gastric lesions. We design the case report table by consulting the literature, and then collect patient information, and speculate the relevant influencing factors through the evaluation of the quality of gastric environmental preparation of the examination results. the ultimate goal is to reduce the missed diagnosis rate and misdiagnosis rate and the waste of clinical resources, to prepare the gastric environment more pertinently, and to provide certain guiding significance for the preparation of gastric environment in clinical magnetically controlled capsule endoscopy.
- Conditions
- Capsule Endoscopy
- Keywords
- Magnetically Controlled Capsule Gastroscopy, Influencing Factors, Gastric Preparation Quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| well prepared | GCS was the total scores of all six land-marks, ranging from 6 (completely unprepared) to 24 (perfect). We define that the stomach is well prepared when GCS ≥ 18 | |
| inadequate prepared | GCS was the total scores of all six land-marks, ranging from 6 (completely unprepared) to 24 (perfect). We define that GCS < 18 is inadequate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCS score was used to evaluate the quality of gastric preparation
GCS score was used to evaluate the quality of gastric preparation. GCS was defined as the sum of the scores of six major anatomical markers of the stomach (heart, fundus, body, horn, sinus, and pylorus).A 4-point grading system was used to define cleanliness as excellent (no mucus and foam attachment :4 points);Good (there is a small amount of mucus and foam, but it does not affect the test: score 3 points);Average (with a fair amount of mucus or foam).Failure to complete a completely reliable examination :2 points);Poor (large amount of mucus or foam residue :1 point).The GCS is the total score for all six landmarks, ranging from 6 (completely unprepared) to 24 (perfect).Gastric preparation was defined as sufficient when GCS≥18 and insufficient when GCS<18.
Measured: 24 months
Questionnaire data were used to analyze the influencing factors
Before the examination, the subjects were required to fill in a questionnaire about the influencing factors of the quality of stomach preparation. According to GCS, the subjects were divided into fully prepared group and inadequately prepared group. Finally, statistical analysis was used to find the influencing factors that had statistical significance with the quality of stomach preparation according to the questionnaire content.
Measured: 24 months
Secondary outcomes (2)
The number of positive lesions
The positive lesions detected in this study refer to some focal lesions of the stomach, including polyps, ulcers, gastric varices, submucosal tumors and so on.The lesions were identified by physicians who had performed magnetic capsule gastroscopy in more than 400 cases.
Measured: 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
The safety of MCCG includes the acceptability or adverse events of MCCG preparation and examination, which is defined as symptoms or signs such as drinking water, examination and swallowing capsules, such as monitoring abdominal distension, nausea or vomiting.we count the number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start22 Jun 2021
- Primary completion1 Aug 2022
- Study completionMar 2023 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933643
- Sponsor's protocol ID
- 2020SDU-QILU-072
- Status last verified
- Feb 2023
- First submitted
- 19 May 2021
- Last updated
- 3 Feb 2023
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Influencing Factors of Gastric Preparation Quality for Magnetically Controlled Capsule Gastroscopy
- ClinicalTrials.gov ID
- NCT04933643
- Acronym / sponsor ID
- 2020SDU-QILU-072
- Conditions
- Capsule Endoscopy
- Keywords
- Magnetically Controlled Capsule Gastroscopy, Influencing Factors, Gastric Preparation Quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 22 Jun 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.
The invention of magnetically controlled capsule gastroscopy makes the movement of capsule endoscope in the body controllable. Endoscopic doctors can adjust the angle of capsule observation to examine gastric mucosa according to the need of examination. However, The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy. it will reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis. The purpose of this study is to explore the factors affecting the quality of gastroscopy gastric environmental preparation of magnetically capsule.
Detailed description
Magnetically controlled capsule endoscopy is different from ordinary electronic gastroenteroscopy, it can not fill and clean the gastric cavity by water injection. The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy, reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis, so the quality of MCCG gastric environmental preparation is an important factor limiting the accuracy of diagnosis of gastric lesions. We design the case report table by consulting the literature, and then collect patient information, and speculate the relevant influencing factors through the evaluation of the quality of gastric environmental preparation of the examination results. the ultimate goal is to reduce the missed diagnosis rate and misdiagnosis rate and the waste of clinical resources, to prepare the gastric environment more pertinently, and to provide certain guiding significance for the preparation of gastric environment in clinical magnetically controlled capsule endoscopy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| well prepared | – | –GCS was the total scores of all six land-marks, ranging from 6 (completely unprepared) to 24 (perfect). We define that the stomach is well prepared when GCS ≥ 18 |
| inadequate prepared | – | –GCS was the total scores of all six land-marks, ranging from 6 (completely unprepared) to 24 (perfect). We define that GCS < 18 is inadequate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender
Key inclusion criteria (2 listed)
- patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender
- sign informed consent form
Key exclusion criteria (9 listed)
- dysphagia, known or suspected gastrointestinal obstruction、stricture and fistula
- patients with severe somatic diseases unable to complete examination
- known active upper gastrointestinal bleeding
- previous history of upper digestive tract or abdominal surgery to change
- gastrointestinal anatomy
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 |
|---|---|---|
| Other | inadequate prepared, well prepared |
Primary outcome
GCS score was used to evaluate the quality of gastric preparation
Time frame: 24 months
GCS score was used to evaluate the quality of gastric preparation. GCS was defined as the sum of the scores of six major anatomical markers of the stomach (heart, fundus, body, horn, sinus, and pylorus).A 4-point grading system was used to define cleanliness as excellent (no mucus and foam attachment :4 points);Good (there is a small amount of mucus and foam, but it does not affect the test: score 3 points);Average (with a fair amount of mucus or foam).Failure to complete a completely reliable examination :2 points);Poor (large amount of mucus or foam residue :1 point).The GCS is the total score for all six landmarks, ranging from 6 (completely unprepared) to 24 (perfect).Gastric preparation was defined as sufficient when GCS≥18 and insufficient when GCS<18.
Questionnaire data were used to analyze the influencing factors
Time frame: 24 months
Before the examination, the subjects were required to fill in a questionnaire about the influencing factors of the quality of stomach preparation. According to GCS, the subjects were divided into fully prepared group and inadequately prepared group. Finally, statistical analysis was used to find the influencing factors that had statistical significance with the quality of stomach preparation according to the questionnaire content.
2 secondary outcomes
The number of positive lesions
Time frame: 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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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.
Li Yanqing principal investigator
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?
An observational study of 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 9 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 3 Feb 2023. 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 Li Yanqing (053182169385, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCS score was used to evaluate the quality of gastric preparation (time frame: 24 months). The study lists 2 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 3 Feb 2023.