Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

Not Applicable

Completed

• Conditions: GastroIntestinal Bleeding
• Interventions: Device: Nexpowder; Procedure: Conventional Treatment

• Registration Number: NCT05884931
• Lead Sponsor: Next Biomedical Co., Ltd.

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.

Study Timeline

• Study Start: 2022-10-18
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Treatment + Nexpowder	Nexpowder	Conventional Treatment + Nexpowder
Conventional Treatment	Conventional Treatment	Conventional Treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of device malfunction (experimental group)	7 days	Incidence of device malfunction (experimental group)
Death rate	7 days	Death rate
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
Number of Nexpowder applications (experimental group)	7 days	Number of Nexpowder applications (experimental group)
Rate of ease of use (experimental group)	7 days	Rate of ease of use (experimental group)
Blood transfusion case rate	7 days	Blood transfusion case rate
Perforation incidence	7 days	Perforation incidence
Number of usage of Nexpowder (experimental group)	7 days	Number of usage of Nexpowder (experimental group)

Trial Locations

Locations (3)

Chungnam National University Sejong Hospital; 🇰🇷 Sejong, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of