Gastrointestinal DiseaseEndo-mmfiNCT06236594
Application of Multimodal Endoscopic Functional Imaging Technology in the Diagnosis of Common Gastrointestinal Diseases
An observational study of Gastrointestinal Disease, run by Beijing 302 Hospital at 1 site in China.
Trial summary
We plan the study to explore the application of endoscopic laser speckle imaging and multispectral blood oxygen imaging to observe gastrointestinal lesions, as well as the differences in the morphology, density and functional status of mucosal surfaces and deep blood vessels of different gastrointestinal lesions, also… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Disease
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2023to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Meet the inclusion and exclusion criteria.
Who may be able to join
- Age: 18-80 years old, gender is not limited
- Diagnosed or suspected of one of the following common gastrointestinal mucosal diseases: Chronic non-atrophic gastritis, chronic atrophic gastritis, gastric polyps, early gastric cancer, advanced gastric cancer, colon polyps, colon melanosis, inflammatory bowel disease, early colon cancer, advanced colon cancer
- Sign the informed consent form -
Who cannot join
- Combined with cardiovascular and cerebrovascular diseases, or severe impairment of liver, kidney and hematopoietic system;
- mentally ill;
- the presence of bleeding disorders;
- Platelet count<50×10^9/L;
- Inability to tolerate or cooperate with endoscopy;
- Patients with serious complications, such as severe infection, gastrointestinal bleeding, obstruction, perforation, etc.;
- Pregnant or lactating women.
- Refuse to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
Shujuan Li contact
China1 site, 1 recruiting
- Recruiting
The fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071
Wei Shen, +8615001038695, shshenw@sina.com
Shujuan Li, +8601066947300
About this study
We plan the study to explore the application of endoscopic laser speckle imaging and multispectral blood oxygen imaging to observe gastrointestinal lesions, as well as the differences in the morphology, density and functional status of mucosal surfaces and deep blood vessels of different gastrointestinal lesions, also to explore the role of endoscopic multimodal functional imaging in common gastrointestinal diseases, especially in the early diagnosis of gastrointestinal tumors.
Read the detailed description
The current focus of electronic endoscopy is on the morphology and fine structure of the mucosal surface, and there is no effective observation method for the deep structure of the mucosa and the function of blood oxygen binding. However, the multilayer morphology and functions of mucosal vessels under different conditions of digestive tract lesions should be different. Therefore, we propose a method of endoscopic multimodal functional imaging to the conventional endoscopic examinations observing the mucosa of the digestive tract, which is based on the existing electronic endoscope, laser speckle contrast imaging and multispectral blood oxygen imaging technology. Laser irradiation was given to obtain the information of coherent light on the mucosal surface and deep scattering of coherent light to obtain multi-level vascular distribution information, and multispectral irradiation imaging was carried out to obtain the oxygenation situation of the mucosa. Finally, we may find the differences of images of deep blood vessels among common gastrointestinal diseases, which could help us to make early diagnosis of gastrointestinal tumors noninvasively.
- Conditions
- Gastrointestinal Disease
- Keywords
- endoscopic laser speckle imaging, multispectral blood oxygen imaging, gastrointestinal lesions, early diagnosis, gastrointestinal tumors
- Medical subject headings
- Gastrointestinal Diseases, Disease, Digestive System Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality rate
The main evaluation index (image quality rate) is based on FAS(Full Analysis Set) and PPS(Per Protocol Set), for statistical description. Image quality rate Calculation formula: image excellent rate = number of cases with excellent or good image quality evaluation ÷ number of subjects undergoing multimodal endoscopy × 100%.
Measured: one year
Secondary outcomes (1)
Diagnosis accuracy according to image
(1) Endoscopy examinations combined with laser speckle imaging and Doppler blood oxygen imaging can realize multi-level vascular observation and photographing of the mucosa, and the imaging analyzer will analyzes and synthesizes the two-dimensional map of laser speckle and blood oxygen imaging of the mucosa. Endoscopist will make diagnosis according to the image they get. (2) After endoscopic biopsy or endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESD) obtaining tissue specimens, the pathology was observed by conventional HE staining or immunohistochemistry. (3) The results of comparison are divided into conformity, partial conformity and non-conformity.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start18 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236594
- Sponsor's protocol ID
- multimodal endoscopic imaging
- Acronym
- Endo-mmfi
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Multimodal Endoscopic Functional Imaging Technology in the Diagnosis of Common Gastrointestinal Diseases
- ClinicalTrials.gov ID
- NCT06236594
- Acronym / sponsor ID
- Endo-mmfi / multimodal endoscopic imaging
- Conditions
- Gastrointestinal Disease
- Keywords
- endoscopic laser speckle imaging, multispectral blood oxygen imaging, gastrointestinal lesions, early diagnosis, gastrointestinal tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Feb 2024 (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.
We plan the study to explore the application of endoscopic laser speckle imaging and multispectral blood oxygen imaging to observe gastrointestinal lesions, as well as the differences in the morphology, density and functional status of mucosal surfaces and deep blood vessels of different gastrointestinal lesions, also to explore the role of endoscopic multimodal functional imaging in common gastrointestinal diseases, especially in the early diagnosis of gastrointestinal tumors.
Detailed description
The current focus of electronic endoscopy is on the morphology and fine structure of the mucosal surface, and there is no effective observation method for the deep structure of the mucosa and the function of blood oxygen binding. However, the multilayer morphology and functions of mucosal vessels under different conditions of digestive tract lesions should be different. Therefore, we propose a method of endoscopic multimodal functional imaging to the conventional endoscopic examinations observing the mucosa of the digestive tract, which is based on the existing electronic endoscope, laser speckle contrast imaging and multispectral blood oxygen imaging technology. Laser irradiation was given to obtain the information of coherent light on the mucosal surface and deep scattering of coherent light to obtain multi-level vascular distribution information, and multispectral irradiation imaging was carried out to obtain the oxygenation situation of the mucosa. Finally, we may find the differences of images of deep blood vessels among common gastrointestinal diseases, which could help us to make early diagnosis of gastrointestinal tumors noninvasively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Meet the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Age: 18-80 years old, gender is not limited
- Diagnosed or suspected of one of the following common gastrointestinal mucosal diseases: Chronic non-atrophic gastritis, chronic atrophic gastritis, gastric polyps, early gastric cancer, advanced gastric cancer, colon polyps, colon melanosis, inflammatory bowel disease, early colon cancer, advanced colon cancer
- Sign the informed consent form -
Key exclusion criteria (8 listed)
- Combined with cardiovascular and cerebrovascular diseases, or severe impairment of liver, kidney and hematopoietic system;
- mentally ill;
- the presence of bleeding disorders;
- Platelet count<50×10^9/L;
- Inability to tolerate or cooperate with endoscopy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Image quality rate
Time frame: one year
The main evaluation index (image quality rate) is based on FAS(Full Analysis Set) and PPS(Per Protocol Set), for statistical description. Image quality rate Calculation formula: image excellent rate = number of cases with excellent or good image quality evaluation ÷ number of subjects undergoing multimodal endoscopy × 100%.
1 secondary outcome
Diagnosis accuracy according to image
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
Shujuan Li contact
Yan Liu principal investigator
Beijing 302 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 Gastrointestinal Disease, run by Beijing 302 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 3 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 1 Feb 2024. 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 Wei Shen (+8615001038695, shshenw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality rate (time frame: one year). 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 1 Feb 2024.