Endoscopic Submucosal DissectionNCT07495137
The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection
A study testing AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking in people with Endoscopic Submucosal Dissection and Endoscopic Submucosal Dissection (ESD), run by Qilu Hospital of Shandong University.
Trial summary
The goal of this clinical trial is to learn if an artificial intelligence (AI) system that identifies bleeding points in real time can help stop bleeding faster during endoscopic submucosal dissection (ESD) - a minimally invasive surgery for early digestive tract cancer or precancerous lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endoscopic Submucosal Dissection, Endoscopic Submucosal Dissection (ESD)
- What is being tested?
- AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Aged 18-80 years;
- Lesions meet the indications for ESD treatment of the esophagus, stomach, or colorectum according to relevant guidelines;
- Anticoagulant drugs have been suspended according to relevant guidelines;
- Patients with American Society of Anesthesiologists (ASA) classification Grade I or II;
- Patients who voluntarily sign the informed consent form.
Who cannot join
- Patients with severe cardiopulmonary diseases, coagulation dysfunction or other severe comorbidities that may increase surgical risks;
- Patients undergoing dialysis treatment;
- Pregnant or lactating women;
- Deemed unsuitable for participation in this study by the principal investigator or other researchers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection (ESD): a Multicenter, Randomized Controlled Trial
The goal of this clinical trial is to learn if an artificial intelligence (AI) system that identifies bleeding points in real time can help stop bleeding faster during endoscopic submucosal dissection (ESD) - a minimally invasive surgery for early digestive tract cancer or precancerous lesions. It will also learn about the AI system's effect on surgery-related problems (like perforation or delayed bleeding) and total surgery time.
The main questions it aims to answer are:
Read more
- Does the AI system shorten the time it takes to stop each bleed during ESD?
- How does the AI system affect the rate of surgery-related problems and total surgery time?
Researchers will compare two groups to see if the AI system improves hemostasis efficiency:
- AI group: During ESD, the AI system will real-time spot and mark bleeding points. Doctors will use these marks to stop bleeding.
- Control group: Doctors will use the same equipment but without the AI system - they will find and stop bleeding using their own experience.
Participants will:
- Have ESD surgery for esophageal, stomach, or colorectal lesions that need this treatment;
- Be randomly assigned to either the AI group or the control group;
- Attend follow-up checks in 14 days after surgery to check for complications;
- Have their surgery videos reviewed by experts to record hemostasis time and total surgery time.
- Being tested
- AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking
- Keywords
- Endoscopic submucosal dissection, Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and markingDevice
Patients undergo ESD with real-time AI assistance. During the operation, the pre-trained and validated AI system continuously analyzes endoscopic images to automatically identify and mark active bleeding points in real time. Endoscopists perform hemostatic operations (e.g., coagulation with hemostatic forceps or electrosurgical knives) based on the AI-generated marks to target bleeding sites promptly.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted Group | Experimental | During the endoscopic submucosal dissection (ESD) procedure, an artificial intelligence (AI) real-time bleeding point recognition system is utilized. The system dynamically analyzes endoscopic images to identify and mark bleeding sites in real time. Endoscopists perform hemostatic operations promptly based on these AI-generated markers. Receives: Device: AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking |
| Conventional treatment group | No intervention | Patients undergo ESD using the same hardware platform, but the AI system is deactivated. Hemostatic decisions and operations are solely dependent on the endoscopists' clinical experience-they independently judge the location of bleeding points and perform hemostasis without AI assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average single hemostasis time
Measured: Periprocedural
Secondary outcomes (3)
Incidence of postoperative complications
Complications include intraoperative and postoperative perforation, damage to the muscularis propria, etc
Measured: 14 days post-procedure
Total operation duration
Measured: Periprocedural
Psychological stress experienced by the endoscopist
Be evaluated subjectively on a five point scale
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Submucosal DissectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, Shandong Provincial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495137
- Sponsor's protocol ID
- 2026SDU-QILU-1
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection (ESD): a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07495137
- Acronym / sponsor ID
- 2026SDU-QILU-1
- Keywords
- Endoscopic submucosal dissection, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, Shandong Provincial Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (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 goal of this clinical trial is to learn if an artificial intelligence (AI) system that identifies bleeding points in real time can help stop bleeding faster during endoscopic submucosal dissection (ESD) - a minimally invasive surgery for early digestive tract cancer or precancerous lesions. It will also learn about the AI system's effect on surgery-related problems (like perforation or delayed bleeding) and total surgery time.
The main questions it aims to answer are:
- Does the AI system shorten the time it takes to stop each bleed during ESD?
- How does the AI system affect the rate of surgery-related problems and total surgery time?
Researchers will compare two groups to see if the AI system improves hemostasis efficiency:
- AI group: During ESD, the AI system will real-time spot and mark bleeding points. Doctors will use these marks to stop bleeding.
- Control group: Doctors will use the same equipment but without the AI system - they will find and stop bleeding using their own experience.
Participants will:
- Have ESD surgery for esophageal, stomach, or colorectal lesions that need this treatment;
- Be randomly assigned to either the AI group or the control group;
- Attend follow-up checks in 14 days after surgery to check for complications;
- Have their surgery videos reviewed by experts to record hemostasis time and total surgery time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted Group | Experimental | Device: AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and markingDuring the endoscopic submucosal dissection (ESD) procedure, an artificial intelligence (AI) real-time bleeding point recognition system is utilized. The system dynamically analyzes endoscopic images to identify and mark bleeding sites in real time. Endoscopists perform hemostatic operations promptly based on these AI-generated markers. |
| Conventional treatment group | No intervention | –Patients undergo ESD using the same hardware platform, but the AI system is deactivated. Hemostatic decisions and operations are solely dependent on the endoscopists' clinical experience-they independently judge the location of bleeding points and perform hemostasis without AI assistance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-80 years;
- Lesions meet the indications for ESD treatment of the esophagus, stomach, or colorectum according to relevant guidelines;
- Anticoagulant drugs have been suspended according to relevant guidelines;
- Patients with American Society of Anesthesiologists (ASA) classification Grade I or II;
- Patients who voluntarily sign the informed consent form.
Key exclusion criteria (4 listed)
- Patients with severe cardiopulmonary diseases, coagulation dysfunction or other severe comorbidities that may increase surgical risks;
- Patients undergoing dialysis treatment;
- Pregnant or lactating women;
- Deemed unsuitable for participation in this study by the principal investigator or other researchers.
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 real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and markingPatients undergo ESD with real-time AI assistance. During the operation, the pre-trained and validated AI system continuously analyzes endoscopic images to automatically identify and mark active bleeding points in real time. Endoscopists perform hemostatic operations (e.g., coagulation with hemostatic forceps or electrosurgical knives) based on the AI-generated marks to target bleeding sites promptly. | Device | AI-assisted Group |
Primary outcome
Average single hemostasis time
Time frame: Periprocedural
3 secondary outcomes
Incidence of postoperative complications
Time frame: 14 days post-procedure
Total operation duration
Time frame: Periprocedural
Psychological stress experienced by the endoscopist
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking in people with Endoscopic Submucosal Dissection and Endoscopic Submucosal Dissection (ESD), run by Qilu Hospital of Shandong University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Li (+86-18560086106, qilulizhen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average single hemostasis time (time frame: Periprocedural). 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 Sep 2026.