GastroIntestinal Bleeding
Conditions
Brief summary
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
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.
Interventions
DEVICENexpowder
Hemostatic powder for endoscopy after colonoscopy polypectomy
PROCEDUREConventional Treatment
Standard hemostatic procedure
Sponsors
Next Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult volunteers aged 19 or older during screening 2. 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) 3. 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
1. Upper gastrointestinal bleeding 2. If ulcerative bleeding is not caused by the procedure 3. If you are suffering from a blood clotting disorder 4. Aspirin and anticoagulant medications cannot be discontinued 5. Pregnant or lactating 6. Where colonoscopy is prohibited due to comorbid diseases, etc 7. If the bleeding area cannot be identified or the bleeding area cannot be reached with an endoscope 8. If you have participated in a relevant clinical trial that may affect the results of this study within the last one month 9. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption 10. A person who is hypersensitive to food additive Blue No. 1 or has a history of allergies 11. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis) | 30 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 7 days of successful endoscopic hemostasis | 7 days | Rate of rebleeding within 7 days of successful endoscopic hemostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perforation incidence | 7 days | Perforation incidence |
| Death rate | 7 days | Death rate |
| Blood transfusion case rate | 7 days | Blood transfusion case rate |
| Number of usage of Nexpowder (experimental group) | 7 days | Number of usage of Nexpowder (experimental group) |
| Incidence of device malfunction (experimental group) | 7 days | Incidence of device malfunction (experimental group) |
| Rate of ease of use (experimental group) | 7 days | Rate of ease of use (experimental group) |
| Number of Nexpowder applications (experimental group) | 7 days | Number of Nexpowder applications (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 | Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period | 30 days | Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period |
Countries
South Korea
Outcome results
None listed