Nexpowder
DeviceHemostatic powder for endoscopy after colonoscopy polypectomy
NCT Number: NCT05884931
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Chungbuk National University Hospital, Cheongju-si, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hemostatic powder for endoscopy after colonoscopy polypectomy
Standard hemostatic procedure
Time frame: 7 days
Rate of rebleeding within 7 days of successful endoscopic hemostasis
Time frame: 30 days
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Time frame: 5 min
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: 7 days
Perforation incidence
Time frame: 7 days
Death rate
Time frame: 7 days
Blood transfusion case rate
Time frame: 7 days
Number of Nexpowder applications (experimental group)
Time frame: 7 days
Number of usage of Nexpowder (experimental group)
Time frame: 7 days
Incidence of device malfunction (experimental group)
Time frame: 7 days
Rate of ease of use (experimental group)
Time frame: 30 days
Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period
Next Biomedical Co., Ltd.
Industry
A Prospective, Multicenter, Open-label, Randomized Controlled Study to Evaluate Safety and Effectiveness of Endoscopic Hemostatic Powder, 'Nexpowder' for Hemostatic Treatments of Lower Gastrointestinal Bleeding After Colon Polypectomy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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