In patients who show signs of bleeding and bleeding after polypectomy such as EMR and ESD for polyps with a diameter of 2 cm or more in the lower gastrointestinal tract, the effectiveness and safety of Nexpowder as an endoscopic hemostatic treatment are confirmed.
Total number of target subjects 66 Test group 33 / Control group: 33 If endoscopic polypectomy is performed on polyps of 2cm or more, the probability of bleeding as a complication is 6.5%. This clinical study is an observational study to confirm the safety and effectiveness of Nexpowder, an endoscopic hemostatic powder after colonoscopy polypectomy, and an exploratory evaluation of 60 patients is conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Hemostatic powder for endoscopy after colonoscopy polypectomy
Standard hemostatic procedure
Chungbuk National University Hospital
Cheongju-si, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chungnam National University Sejong Hospital
Sejong, South Korea
Rate of rebleeding within 7 days of successful endoscopic hemostasis
Rate of rebleeding within 7 days of successful endoscopic hemostasis
Time frame: 7 days
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Time frame: 30 days
Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group
Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group
Time frame: 5 min
Perforation incidence
Perforation incidence
Time frame: 7 days
Death rate
Death rate
Time frame: 7 days
Blood transfusion case rate
Blood transfusion case rate
Time frame: 7 days
Number of Nexpowder applications (experimental group)
Number of Nexpowder applications (experimental group)
Time frame: 7 days
Number of usage of Nexpowder (experimental group)
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Number of usage of Nexpowder (experimental group)
Time frame: 7 days
Incidence of device malfunction (experimental group)
Incidence of device malfunction (experimental group)
Time frame: 7 days
Rate of ease of use (experimental group)
Rate of ease of use (experimental group)
Time frame: 7 days