None listed
Conditions
Interventions
Medical Device : Each group will be randomly assigned at Visit2 (day 0).
1. Test group : CEGP003
- Usage / Capacity : Disposable / Max Daily Usage 9g
- Information: How to apply to hemostatic part in
Sponsors
CGBio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A man or woman 19 years of age or older 2. Peptic ulcers or active bleeding after EMR or ESD procedures, or high risk of rebleeding (non-bleeding visible vessels). 3. Those who are willing to participate in the examination, to follow treatments and procedures, and to visit the hospital for all observational evaluations 4. Person who voluntarily signed written consent after explaining the purpose and method of this study
Exclusion criteria
Exclusion criteria: [Checked at the time of screening] 1. Subject with uncorrected coagulation disorder(PLT 2) 2. Subject who cannot stop taking antiplatelet drugs or anticoagulants except aspirin for the treatment 3. Pregnant or lactating women 4. Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF 5. Subjects who have undergone endoscopically therapies within the last 7 days 6. Subjects who are contraindicated for endoscopic treatment due to accompanying diseases 7. Subjects who are Participants in other interventions that may affect clinical trial results within the last three months 8. Subjects who is determined to be ineligible for participation in this clinical trial based on other investigator's judgment. [Checked on the day of endoscopy procedure] 9. Subjects who Endoscopic findings that do not correspond to Ia ~ IIb according to the Forrest classification method and that the bleeding pattern cannot be treated with a test device or a control device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Initial hemostasis rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent bleeding rate according to operator questionnaire (skill, difficulty, satisfaction);Delayed hemostasis rate according to operator questionnaire (skill, difficulty, satisfaction);The operator's satisfaction with test group and control group;Recurrent bleeding rate;Delayed hemostasis rate;Time required for treatment;Identify Forrest Classification Changes;Confirmation of ulcer treatment effect (Sakita classification, ulcer size);Initial hemostasis rate according to operator questionnaire (skill, difficulty, satisfaction) | — |
Countries
Korea, Republic of
Contacts
Public ContactPark Chul
Yonsei University Health System, Severance Hospital
Outcome results
None listed