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This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.
CEGP003 is wound dressing solution containing Hydroxyethyl-cellulose and EGF. Epidermal growth factor (EGF) stimulates cell growth and differentiation by binding to its receptor, which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a peptic ulcers bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEGP003 | Experimental |
| |
| Injection Tx | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEGP003 | Device | Application of CEGP003 to peptic ulcer bleeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial hemostasis rate | Endoscopically verified cessation of bleeding for at least 10 minutes after treatment. | Within 10 minutes after first endoscopy session |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent bleeding rate | If any of the following conditions are met, an endoscopy will verify for rebleeding.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Haeng Lee, MD. PhD. | Inha University Hospital | Principal Investigator |
| Su Jin Hong, MD. PhD. | Soon Chun Hyang University | Principal Investigator |
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| ID | Term |
|---|---|
| D010438 | Peptic Ulcer Hemorrhage |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
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| Injection Tx | Device | Injection of epinephrine to peptic ulcer bleeding |
|
|
| Within 72 hours |
| Time required for treatment | The time from when the endoscope is inserted to when the endoscope treatment is completed. | 0 day |
| Wound healing effect of peptic ulcer | Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa. | After 3 days (72 hours) |
| Usability for the delivery system | Evaluation of success for the delivery system | 0 day |
| D013568 | Pathological Conditions, Signs and Symptoms |