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

April 24, 2025 updated by: Next Biomedical Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 30 days post treatment
30 days after successful endoscopic hemostasis
30 days post treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Next Biomedical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe