Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract

Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract: A Prospective, Multi-Center, Single-Arm, Open-Label, Pilot Clinical Trial

Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Gastrointestinal Bleeding; Diverticular Bleeding
• Intervention / Treatment: Device: Nexpowder™

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheongju, Korea, Republic of
    • Chungbuk National University Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of
    • Chosun University Hospital
  • Sejong, Korea, Republic of
    • Sejong Chungnam National University Hospital
  • Seoul, Korea, Republic of
    • Kangdong KyungHee University Hospital
  • Yangsan, Korea, Republic of
    • Yangsan Busan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 19 years or older at the time of screening
• Patients diagnosed with diverticular bleeding

Exclusion Criteria:

• Patients diagnosed with upper gastrointestinal bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nexpowder Treatment Arm	Device: Nexpowder™; Nexpowder™ hemostatic powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebleeding rate	30 days after successful endoscopic hemostasis	30 days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis rate	Hemostasis rate	Immediately after the procedure
Rebleeding rate	Rebleeding rate	7 days post treatment

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: Nexpowder_008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No