None listed
Conditions
Interventions
Medical Device : In this study, the maximum daily allowable dose of Nexpowder™ is 6 g, so a total of 3 g products can be applied twice.
After endoscopic hemostasis, the timing of discharge is determin
Sponsors
Chungnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult volunteers 19 years of age or older at screening 2) clinically determined diverticulum bleeding, etc 3) Subjects who voluntarily agree to participate in the clinical study and comply with the research plan (Written consent from the subject's legal representative is required if the researcher determines that voluntary consent is not possible due to the elderly over 80 years of age or other emergencies)
Exclusion criteria
Exclusion criteria: 1) a patient diagnosed with upper gastrointestinal bleeding 2) If endoscopy is contraindicated due to comorbidities 3) a woman who is pregnant or lactating or who plans to become pregnant within one month of the procedure 4) If colonoscopy is contraindicated 5) If it is impossible to identify the bleeding area or if it is impossible to reach the bleeding area with an endoscope 6) Participation in relevant clinical trials that may affect the results of this study within the last 1 month 7) Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8) A person who is hypersensitivity to food additive blue No. 1 or has a history of allergies 9) If the researcher deems it inappropriate to participate in the clinical trial due to other reasons other than the above selection/exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rebleeding rate within 30 days of successful endoscopic hemostasis ;hemostasis rate ;Rebleeding rate within 7 days of successful endoscopic hemostasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Capacity with Nexpowder ;Abnormal cases related to the endoscopy of the lower gastrointestinal tract (pancreatitis, cholangitis, diverticulum rupture, perforation, over-distortion, or intestinal obstruction, blood transfusion with abscess formation); Adverse event during the 30-day follow-up period | — |
Countries
Korea, Republic of
Contacts
Public ContactYeon Jung Youn
Chungnam National University Hospital
Outcome results
None listed