None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : Each group will be randomly assigned to either the experimental group or the control group at Visit 2.
Experimental Group: CG Gel
Dosage and Administration: dispos
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A man or woman 19 years of age or older. 2. Patients undergoing endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for gastric tumors (dysplasia, early gastric cancer). 3. Individuals willing to participate in the trial, comply with treatment and procedures, and visit the hospital for all required observational assessments. 4. Individuals who have received an explanation of the purpose, methods, etc., of this clinical trial and voluntarily signed the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically significant cardiopulmonary disease. 2. Subjects with severe renal dysfunction. 3. Subjects with severe bone marrow dysfunction. 4. Subjects with severe blood coagulation disorders. 5. Subjects with active hepatitis, liver disease that is poorly controlled with treatment, or severe liver dysfunction. 6. Subjects with severe neurological or psychiatric comorbidities. 7. Pregnant or breastfeeding women. 8. Subjects who have an adverse reaction to any component of the investigational medical device (hydroxyethyl cellulose). 9. Subjects who have undergone another endoscopic hemostatic procedure within 7 days prior to the trial. 10. Subjects deemed inappropriate for participation in this clinical trial by the investigator. 11. Subjects for whom the amount of post-procedural bleeding is deemed unmanageable by the investigational device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the difference in bleeding rates up to 4 weeks after the procedure between the control group, which received conventional hemostasis treatment, and the CGGel group, applied to iatrogenic ulcer lesions that occurred after endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the difference in acute bleeding rates between the two groups;Comparison of the difference in delayed bleeding rates between the two groups;Procedure duration;Post-procedure complication rate;Operator satisfaction with the treatment in the experimental and control groups | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunsoo Chung
Seoul National University Hospital
Outcome results
None listed