Trials / Completed
CompletedNCT02978391
UI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD
A Prospective, Multicenter, Single-blind, Controlled Clinical Trial to Confirm the Efficacy and Safety of 'UI-EWD', a Wound Dressing Used for Wound Protection and Hemostasis After Ulcer Bleeding Due to Peptic Ulcer, EMR and ESD
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Next Biomedical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.
Detailed description
UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. This study has been designed to observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | UI-EWD Hemostatic system | Adhesive endoscopic hemostats, powder type |
| DRUG | epinephrine endoscopic injection (conventional therapy) | endoscopic submucosal injection of epinephrine (1: 10,000) |
Timeline
- Start date
- 2016-05-23
- Primary completion
- 2016-11-30
- Completion
- 2017-09-18
- First posted
- 2016-11-30
- Last updated
- 2022-04-08
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02978391. Inclusion in this directory is not an endorsement.