Non-varicose venous gastrointestinal bleeding
Conditions
Interventions
Trial Group:Treatment was carried out using the degradable endoscopic sealing gel device produced by Shanghai Yisimiao Medical Devices Co., Ltd.
Instrument Name: Biodegradable Endoscopic Sealing Gel D
Sponsors
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.18 years old to 75 years old, gender not limited 2.Diagnosed as non-varicose gastrointestinal bleeding by endoscopic examination, with lesions of upper or lower gastrointestinal bleeding classified as Forrest grade ?a, ?b, ?a or ?b; The causes of gastrointestinal bleeding include EMR(Endoscopic mucosal resection), ESD(endoscopic submucosal dissection), resection of gastric and colorectal tumors, and other inflammatory, neoplastic or ulcerative bleeding, etc 3.Fully understand the trial content, voluntarily participate in the clinical trial and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. There is a consciousness disorder or hemorrhagic shock 2. Intestinal obstruction, gastrointestinal fistula or suspected gastrointestinal perforation 3. Abnormal anatomical structure or inability to tolerate endoscopic examination 4. Coagulation dysfunction (platelet count 2) 5. Liver and kidney dysfunction (ALT or AST exceeding three times the upper limit of normal; SCr exceeding three times the upper limit of normal) 6. Anticoagulant or antiplatelet drugs have been used within 7 days before the operation 7. Having taken glucocorticoids within 6 weeks before the operation (excluding inhalers, eye drops, and topical medications) 8. The bleeding site has received other endoscopic or surgical treatments within 30 days before the operation 9. Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 10. Known to be allergic to Brilliant Blue FCF 11. Pregnant or lactating women 12. Currently participating in clinical trials of other drugs or medical devices 13. Situations where other researchers consider it unsuitable to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of hemostasis within 5 minutes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of equipment usage;The incidence of rebleeding at 3 days and 30 days after the operation; | — |
Countries
China
Contacts
Public ContactLiao Zhuan
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Outcome results
None listed