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Not yet recruitingNCT06939907Updated Apr 25, 2025

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

An interventional study of Nexpowder™ in Lower Gastrointestinal Bleeding and Diverticular Bleeding, sponsored by Next Biomedical Co., Ltd.. Not yet recruiting at 6 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Next Biomedical Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Lower Gastrointestinal Bleeding
  • Diverticular Bleeding

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03

In context

Diverticular Diseases

44 studies on the registry are indexed under Diverticular Diseases; 9 are open to participants now.

This study's planned enrollment of 60 is below the median of 81 across 31 interventional studies indexed under Diverticular Diseases.

Browse Diverticular Diseases studies →

Lead sponsor

Next Biomedical Co., Ltd. is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients diagnosed with upper gastrointestinal bleeding
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Nexpowder Treatment Arm

    Device: Nexpowder™

Interventions

  • DeviceNexpowder™

    Nexpowder™ hemostatic powder

06

What researchers measure

Primary outcomes

  1. Rebleeding rate

    30 days after successful endoscopic hemostasis

    Time frame: 30 days post treatment

Secondary outcomes

  1. Hemostasis rate

    Hemostasis rate

    Time frame: Immediately after the procedure

  2. Rebleeding rate

    Rebleeding rate

    Time frame: 7 days post treatment

07

Study locations

6 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06939907
Lead sponsor
Next Biomedical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 23, 2025
Start date
Jun 2025 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Apr 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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