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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
Application of CEGP003 to peptic ulcer bleeding
Injection of epinephrine to peptic ulcer bleeding
Initial hemostasis rate
Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.
Time frame: Within 10 minutes after first endoscopy session
Recurrent bleeding rate
If any of the following conditions are met, an endoscopy will verify for rebleeding. * Associated with overt signs of GI bleed (melena, and/or hematemesis) * Instability of Vital signs (\<80/60 mmHg of blood pressure, and/or \>120 beats/min of pulse) * Decrease in hemoglobin of at least 2 g/dl after Initial hemostasis * bleeding can be confirmed directly (direct visualization)
Time frame: Within 72 hours
Time required for treatment
The time from when the endoscope is inserted to when the endoscope treatment is completed.
Time frame: 0 day
Wound healing effect of peptic ulcer
Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.
Time frame: After 3 days (72 hours)
Usability for the delivery system
Evaluation of success for the delivery system
Time frame: 0 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.