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A prospective, multicenter, randomized, controlled clinical trial to evaluate the efficacy and safety of biodegradable endoscopic sealed-gel device for non-variceal upper gastrointestinal bleeding

A prospective, multicenter, randomized, controlled clinical trial to evaluate the efficacy and safety of biodegradable endoscopic sealed-gel device for non-variceal upper gastrointestinal bleeding

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115110
Enrollment
Unknown
Registered
2025-12-22
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-varicose upper gastrointestinal bleeding

Interventions

Experimental Group:The treatment was carried out using the endoscopic desealing gel device produced by Shanghai Yisimiao Medical Devices Co., LTD
Control group:Treatment is carried out using thermocoagulation and/or mechanical hemostasis

Sponsors

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.18 age < =age < =75 age, gender unlimited 2. Confirmed as non-varicose upper gastrointestinal bleeding under gastrointestinal microscopy and requiring gastrointestinal exposure Take a tourniquet. 3. Fully understand the content of the trial, voluntarily participate in the clinical trial and sign the informed consent

Exclusion criteria

Exclusion criteria: 1. There is a consciousness disorder or bloodless shock; 2. Bowel obstruction, gastrointestinal fistula or suspected gastrointestinal perforation; 3. Anatomy abnormal or unable to withstand an endoscopy; 4.Coagulation dysfunction (platelets 2); 5. Liver and kidney dysfunction (AST or ALT exceeding three times the upper limit of normal); SCr exceeds 3 times the normal upper limit); 6. Anticoagulant or antiplatelet drugs were used in the seven days prior to surgery; 7. Have taken glucocorticoids within 6 weeks prior to surgery (excluding inhalers, eye drops, topical ophthalmic medications); 8. Within 30 days prior to surgery, the bleeding site has undergone other endoscopic or surgical treatments; 9. Known for galactose intolerance, Lapp lactase deficiency, or uveose-galactose malabsorption; 10. Known allergy to Brilliant Blue FCF (Brilliant Blue FCF); 11. Women who are pregnant or breastfeeding; 12. Participating in clinical trials for other drugs or medical devices; 13. Circumstances that other investigators believe are not suitable to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
The effective rate of hemostasis within 5 minutes;

Secondary

MeasureTime frame
Evaluation of equipment usage;Incidence of re-bleeding 3 days and 30 days post-surgery.;

Countries

China

Contacts

Public ContactLiao Zhuan

The First Affiliated Hospital of the Naval Medical University (Changhai Hospital, Shanghai).

zhuanleo@126.com+86 187 2182 8503

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026