Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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GastroIntestinal Bleeding

Intervention / Treatment
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* Device: Nexpowder
* Procedure: Conventional Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult volunteers aged 19 or older during screening A person who is scheduled to perform polypectomy for polyps with a diameter of 2 cm or more, such as Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD) If the researcher agrees to voluntarily participate in the clinical study and determines that the subject cannot voluntarily consent due to the elderly aged 80 or older or other emergency situations, a written consent of the subject's legal representative is required Exclusion Criteria: Upper gastrointestinal bleeding If ulcerative bleeding is not caused by the procedure If you are suffering from a blood clotting disorder Aspirin and anticoagulant medications cannot be discontinued Pregnant or lactating Where colonoscopy is prohibited due to comorbid diseases, etc If the bleeding area cannot be identified or the bleeding area cannot be reached with an endoscope If you have participated in a relevant clinical trial that may affect the results of this study within the last one month Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption A person who is hypersensitive to food additive Blue No. 1 or has a history of allergies In the case where the researcher determines that it is inappropriate to participate in clinical trials due to other reasons other than the above selection exclusion criteria

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Treatment<br>Conventional Treatment | Procedure: Conventional Treatment<br>* Standard hemostatic procedure<br>|
| Experimental: Conventional Treatment + Nexpowder<br>Conventional Treatment + Nexpowder | Device: Nexpowder<br>* Hemostatic powder for endoscopy after colonoscopy polypectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rebleeding within 7 days of successful endoscopic hemostasis | Rate of rebleeding within 7 days of successful endoscopic hemostasis | 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) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 min | 
| Perforation incidence | Perforation incidence | 7 days | 
| Death rate | Death rate | 7 days | 
| Blood transfusion case rate | Blood transfusion case rate | 7 days | 
| Number of Nexpowder applications (experimental group) | Number of Nexpowder applications (experimental group) | 7 days | 
| Number of usage of Nexpowder (experimental group) | Number of usage of Nexpowder (experimental group) | 7 days | 
| Incidence of device malfunction (experimental group) | Incidence of device malfunction (experimental group) | 7 days | 
| Rate of ease of use (experimental group) | Rate of ease of use (experimental group) | 7 days |