NCT07495137

The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection

Not yet recruiting NA Last updated 27 March 2026

What this trial tests

NA trial testing AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking in Endoscopic Submucosal Dissection in 160 participants. Not yet recruiting.

Timeline

31 March 2026

Primary endpoint
30 June 2027

31 December 2027

Quick facts

Lead sponsor	Qilu Hospital of Shandong University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	160
Start date	31 March 2026
Primary completion	30 June 2027
Estimated completion	31 December 2027

Drugs / interventions tested

• AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking

Conditions studied

• Endoscopic Submucosal Dissection — all drugs for Endoscopic Submucosal Dissection →
• Endoscopic Submucosal Dissection (ESD) — all drugs for Endoscopic Submucosal Dissection (ESD) →

Sponsor

Qilu Hospital of Shandong University

Who can join

Adults 18 to 80, any sex, with Endoscopic Submucosal Dissection or Endoscopic Submucosal Dissection (ESD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

1. Does the AI system shorten the time it takes to stop each bleed during ESD?
2. 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:

1. AI group: During ESD, the AI system will real-time spot and mark bleeding points. Doctors will use these marks to stop bleeding.
2. 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:

1. Have ESD surgery for esophageal, stomach, or colorectal lesions that need this treatment;
2. Be randomly assigned to either the AI group or the control group;
3. Attend follow-up checks in 14 days after surgery to check for complications;
4. Have their surgery videos reviewed by experts to record hemostasis time and total surgery time.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.