Lower Gastrointestinal BleedingNCT06939907
Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract
A study testing Nexpowder™ in people with Lower Gastrointestinal Bleeding and Diverticular Bleeding, run by Next Biomedical Co., Ltd. at 6 sites in South Korea.
Trial summary
Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lower Gastrointestinal Bleeding, Diverticular Bleeding
- What is being tested?
- Nexpowder™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Jun 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older at the time of screening
- Patients diagnosed with diverticular bleeding
Who cannot join
- Patients diagnosed with upper gastrointestinal bleeding
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites
Chungbuk National University Hospital
Cheongju-si
Chungnam National University Hospital
Daejeon
Chosun University Hospital
Gwangju
Sejong Chungnam National University Hospital
Sejong
Kangdong Kyunghee University Hospital
Seoul
Yangsan Busan National University Hospital
Yangsan
About this study
Official title: 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
- Being tested
- Nexpowder™
- Medical subject headings
- Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexpowder™Device
Nexpowder™ hemostatic powder
| Study group | Role | What they receive |
|---|---|---|
| Nexpowder Treatment Arm | Experimental | Not described Receives: Device: Nexpowder™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate
30 days after successful endoscopic hemostasis
Measured: 30 days post treatment
Secondary outcomes (2)
Hemostasis rate
Hemostasis rate
Measured: Immediately after the procedure
Rebleeding rate
Rebleeding rate
Measured: 7 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Next Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939907
- Sponsor's protocol ID
- Nexpowder_008
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06939907
- Acronym / sponsor ID
- Nexpowder_008
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Next Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nexpowder Treatment Arm | Experimental | Device: Nexpowder™ |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 19 years or older at the time of screening
- Patients diagnosed with diverticular bleeding
Key exclusion criteria (1 listed)
- Patients diagnosed with upper gastrointestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexpowder™Nexpowder™ hemostatic powder | Device | Nexpowder Treatment Arm |
Primary outcome
Rebleeding rate
Time frame: 30 days post treatment
30 days after successful endoscopic hemostasis
2 secondary outcomes
Hemostasis rate
Time frame: Immediately after the procedure
Rebleeding rate
Time frame: 7 days post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nexpowder™ in people with Lower Gastrointestinal Bleeding and Diverticular Bleeding, run by Next Biomedical Co., Ltd. at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding rate (time frame: 30 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.