ObesityNCT05909124
MCE for Gastric Examination in Obese People
An observational study of Obesity, run by Changhai Hospital at 1 site in China.
Trial summary
This retrospective study aimed to evaluate the feasibility and safety of MCE for the detection of gastric disease in obese people. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MCE
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2023to Oct 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18.5≤BMI<25 or BMI≥30；underwent gastric examination; At least 18 years old；Be able to provide informed consent.
Who may be able to join
- 18.5≤BMI<25 or BMI≥30
- underwent gastric examination;
- At least 18 years old；
- Be able to provide informed consent.
Who cannot join
- With swallowing obstruction or disorders;
- With known or suspected gastrointestinal obstruction, stenosis and fistula;
- Have no conditions for surgery or refuse to undergo any abdominal surgery;
- Be allergic to or have other known contraindication or intolerance to the drug used in the study;
- With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
- Women during pregnancy;
- Currently enrolled in another clinical trial of a drug or device;
- Other conditions determined by the investigator to be inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study to Evaluate the Feasibility and Safety of Magnetically Controlled Capsule Endoscope System in Gastric Examination in Obese People
This retrospective study aimed to evaluate the feasibility and safety of MCE for the detection of gastric disease in obese people.
Read the detailed description
In this study, we evaluated the feasibility and safety of MCE for the detection of gastric disease in obese people by comparing the results of MCE between healthy weight people (18.5≤BMI<25) and obese people (BMI≥30). The observation index included mucosal visualization, gastric transit time, cleanliness of the stomach, detection of lesions and safety evaluation.
- Conditions
- Obesity
- Being tested
- MCE
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCEDevice
underwent MCE examination
| Study group | Role | What they receive |
|---|---|---|
| healthy weight people (18.5≤BMI<25) | 18.5≤BMI<25 Receives: Device: MCE | |
| obese people (BMI≥30) | BMI≥30 Receives: Device: MCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
the degree of gastric mucosal visualization
The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, <70% of the gastric mucosa can be observed.
Measured: 2 weeks
Secondary outcomes (5)
the cleanliness of the stomach
The criteria for judging the cleanliness of the stomach are: excellent : no adhesive mucus and foam, clear field of view; good : a small amount of mucus and foam, but the field of view is not blurred and does not affect the integrity of the examination; average : medium amount of mucus and foam, the field of view is more blurred and affects the integrity of the examination; poor : a large amount of mucus and foam, the field of view is blurred and affects the integrity of the examination.
Measured: 2 weeks
Stomach transmit time
The time of the first stomach image, the first small intestine image and the last image taken by capsule endoscopy were recorded. Stomach transmit time: time of first small intestine image minus time of first stomach image.
Measured: 2 weeks
Small bowel transmit time
The time of the first large intestine image minus the time of the first small intestine image.
Measured: 2 weeks
Incidence of adverse events
The rates of adverse events such as asphyxia by capsule aspiration, swallow disorder, retention, technical failure, and procedural adverse events were recorded.
Measured: 2 weeks
Gastric distention
Assess condition of gastric distention. The criteria for judging gastric distention is: excellent, no obvious gastric folds; good, moderate distance between gastric folds, without folding; fair, short distance between gastric folds, with small amount of folding; poor, no obvious distance between gastric folds, with large amount of folding
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Yangyang Qian, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909124
- Sponsor's protocol ID
- MCE for obese people
- Status last verified
- Jun 2023
- First submitted
- 30 Mar 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.
PubMed 23687601Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
PubMed 27211503Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.
PubMed 25590177
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Evaluate the Feasibility and Safety of Magnetically Controlled Capsule Endoscope System in Gastric Examination in Obese People
- ClinicalTrials.gov ID
- NCT05909124
- Acronym / sponsor ID
- MCE for obese people
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 18 Jun 2023 (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.
This retrospective study aimed to evaluate the feasibility and safety of MCE for the detection of gastric disease in obese people.
Detailed description
In this study, we evaluated the feasibility and safety of MCE for the detection of gastric disease in obese people by comparing the results of MCE between healthy weight people (18.5≤BMI<25) and obese people (BMI≥30). The observation index included mucosal visualization, gastric transit time, cleanliness of the stomach, detection of lesions and safety evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy weight people (18.5≤BMI<25) | – | Device: MCE18.5≤BMI<25 |
| obese people (BMI≥30) | – | Device: MCEBMI≥30 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18.5≤BMI<25 or BMI≥30；underwent gastric examination; At least 18 years old；Be able to provide informed consent.
Key inclusion criteria (4 listed)
- 18.5≤BMI<25 or BMI≥30
- underwent gastric examination;
- At least 18 years old；
- Be able to provide informed consent.
Key exclusion criteria (8 listed)
- With swallowing obstruction or disorders;
- With known or suspected gastrointestinal obstruction, stenosis and fistula;
- Have no conditions for surgery or refuse to undergo any abdominal surgery;
- Be allergic to or have other known contraindication or intolerance to the drug used in the study;
- With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
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 |
|---|---|---|
| MCEunderwent MCE examination | Device | healthy weight people (18.5≤BMI<25), obese people (BMI≥30) |
Primary outcome
the degree of gastric mucosal visualization
Time frame: 2 weeks
The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, <70% of the gastric mucosa can be observed.
5 secondary outcomes
the cleanliness of the stomach
Time frame: 2 weeks
Stomach transmit time
Time frame: 2 weeks
Small bowel transmit time
Time frame: 2 weeks
Incidence of adverse events
Time frame: 2 weeks
Gastric distention
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 23687601Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.
- Background: PubMed 27211503Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
- Background: PubMed 25590177Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.
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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.
Yangyang Qian principal investigator
Changhai Hospital
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 Obesity, run by Changhai Hospital 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 4 inclusion and 8 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 18 Jun 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 Zhuan Liao (86-21-31161004, liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the degree of gastric mucosal visualization (time frame: 2 weeks). 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 NCT05909124, which also lists 3 linked publications.
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 18 Jun 2023.