Gastrointestinal HemorrhageNCT06269588
Efficacy and Safety of Nexpowder™ for Non-variceal, Upper Gastrointestinal Bleeding
A study testing Nexpowder in people with Gastrointestinal Hemorrhage and Hematemesis; With Ulcer, run by Changi General Hospital at 1 site in Singapore.
Trial summary
The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Gastrointestinal Hemorrhage, Hematemesis; With Ulcer, Endoscopy
- What is being tested?
- Nexpowder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged over 21 to 75 years
- Patients with confirmed nonvariceal, upper gastrointestinal bleeding
- Patients who voluntarily agree to the clinical trial with informed consent
- Patients who willing and able to comply with the study protocol
Who cannot join
- Patients with an uncorrected coagulation disorder (PLT<50*109/L, INR>2)
- Patients who are known to be pregnant or in lactation
- Patients who have received another endoscopic treatment for the same part of the body within the days preceding the study
- Patients for whom endoscopic treatment is prohibited due to comorbidity
- Patients for whom the 30-day follow-up period is impossible
- Patients who have participated within the past month in other related clinical trials that could affect the results of the study
- Other cases in which participation in the study is judged inappropriate by the investigators
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Tiing Ang, MRCP (UK), 69365737, ang.tiing.leong@singhealth.com.sg
About this study
Official title: A Prospective, Multi-center, Single-arm, Pilot Clinical Trial to Evaluate Efficacy and Safety of Nexpowder™ for Hemostatic Treatment of Non-variceal, Upper Gastrointestinal Bleeding
The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore
Read the detailed description
24 subjects with non variceal bleeding will be enrolled. The efficacy and safety of Nexpowder™ as primary technique of endoscopci hemostasis will be assessed in this pi,ot study.
- Being tested
- Nexpowder
- Keywords
- gastrointestinal bleeding; hemostatic powder
- Medical subject headings
- Gastrointestinal Hemorrhage, Hematemesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexpowderDevice
Endoscopic hemostasis
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic hemostasis using Nexpowder | Experimental | Subjects with non variceal upper GI bleeding will undergo nndoscopic hemostasis using Nexpowder as primary treatment Receives: Device: Nexpowder |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic hemostasis
endoscopic hemostasis success rate
Measured: up to 24 hours
Secondary outcomes (3)
recurrent bleeding rate on second-look endoscopy
recurrent bleeding rate on second-look endoscopy
Measured: 24 hours
hydrogel persistence rate at the bleeding site
hydrogel persistence rate at the bleeding site
Measured: 24 hours
Recurrent bleeding within 30 days after endoscopic therapy
Recurrent bleeding within 30 days after endoscopic therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies 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
- Model description
- prospective single arm intervention cohort
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Next Biomedical Co., Ltd., Tan Tock Seng Hospital, National University Hospital, Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269588
- Sponsor's protocol ID
- NBM-NP004
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-arm, Pilot Clinical Trial to Evaluate Efficacy and Safety of Nexpowder™ for Hemostatic Treatment of Non-variceal, Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06269588
- Acronym / sponsor ID
- NBM-NP004
- Keywords
- gastrointestinal bleeding; hemostatic powder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Next Biomedical Co., Ltd., Tan Tock Seng Hospital, National University Hospital, Singapore
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Feb 2024 (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.
The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore
Detailed description
24 subjects with non variceal bleeding will be enrolled. The efficacy and safety of Nexpowder™ as primary technique of endoscopci hemostasis will be assessed in this pi,ot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective single arm intervention cohort
| Arm | Type | Receives |
|---|---|---|
| Endoscopic hemostasis using Nexpowder | Experimental | Device: NexpowderSubjects with non variceal upper GI bleeding will undergo nndoscopic hemostasis using Nexpowder as primary treatment |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females aged over 21 to 75 years
- Patients with confirmed nonvariceal, upper gastrointestinal bleeding
- Patients who voluntarily agree to the clinical trial with informed consent
- Patients who willing and able to comply with the study protocol
Key exclusion criteria (7 listed)
- Patients with an uncorrected coagulation disorder (PLT<50*109/L, INR>2)
- Patients who are known to be pregnant or in lactation
- Patients who have received another endoscopic treatment for the same part of the body within the days preceding the study
- Patients for whom endoscopic treatment is prohibited due to comorbidity
- Patients for whom the 30-day follow-up period is impossible
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 |
|---|---|---|
| NexpowderEndoscopic hemostasis | Device | Endoscopic hemostasis using Nexpowder |
Primary outcome
endoscopic hemostasis
Time frame: up to 24 hours
endoscopic hemostasis success rate
3 secondary outcomes
recurrent bleeding rate on second-look endoscopy
Time frame: 24 hours
hydrogel persistence rate at the bleeding site
Time frame: 24 hours
Recurrent bleeding within 30 days after endoscopic therapy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site 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 Gastrointestinal Hemorrhage and Hematemesis; With Ulcer, run by Changi General Hospital at 1 site in Singapore.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic hemostasis (time frame: up to 24 hours). 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 21 Feb 2024.