NCT05884931

Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Next Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• GastroIntestinal Bleeding

Interventions

Type	Name	Description
DEVICE	Nexpowder	Hemostatic powder for endoscopy after colonoscopy polypectomy
PROCEDURE	Conventional Treatment	Standard hemostatic procedure

Timeline

• Start date: 2022-10-18
• Primary completion: 2023-12-01
• Completion: 2023-12-29
• First posted: 2023-06-01
• Last updated: 2024-02-23

Locations

3 sites across 1 country: South Korea