GastroIntestinal BleedingNCT05884931
Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment
A study testing Nexpowder and Conventional Treatment in people with GastroIntestinal Bleeding, run by Next Biomedical Co., Ltd. at 3 sites in South Korea.
Trial summary
In patients who show signs of bleeding and bleeding after polypectomy such as EMR and ESD for polyps with a diameter of 2 cm or more in the lower gastrointestinal tract, the effectiveness and safety of Nexpowder as an endoscopic hemostatic treatment are confirmed. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- GastroIntestinal Bleeding
- What is being tested?
- Nexpowder and Conventional Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 18 Oct 2022to 29 Dec 2023
- Phase
- Interventional
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
- Adult volunteers aged 19 or older during screening
- A person who is scheduled to perform polypectomy for polyps with a diameter of 2 cm or more, such as Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD)
- If the researcher agrees to voluntarily participate in the clinical study and determines that the subject cannot voluntarily consent due to the elderly aged 80 or older or other emergency situations, a written consent of the subject's legal representative is required
Who cannot join
- Upper gastrointestinal bleeding
- If ulcerative bleeding is not caused by the procedure
- If you are suffering from a blood clotting disorder
- Aspirin and anticoagulant medications cannot be discontinued
- Pregnant or lactating
- Where colonoscopy is prohibited due to comorbid diseases, etc
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- If the bleeding area cannot be identified or the bleeding area cannot be reached with an endoscope
- If you have participated in a relevant clinical trial that may affect the results of this study within the last one month
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption
- A person who is hypersensitive to food additive Blue No. 1 or has a history of allergies
- In the case where the researcher determines that it is inappropriate to participate in clinical trials due to other reasons other than the above selection exclusion criteria
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Chungbuk National University Hospital
Cheongju-si
Chungnam National University Hospital
Daejeon
Chungnam National University Sejong Hospital
Sejong
About this study
Official title: A Prospective, Multicenter, Open-label, Randomized Controlled Study to Evaluate Safety and Effectiveness of Endoscopic Hemostatic Powder, 'Nexpowder' for Hemostatic Treatments of Lower Gastrointestinal Bleeding After Colon Polypectomy
In patients who show signs of bleeding and bleeding after polypectomy such as EMR and ESD for polyps with a diameter of 2 cm or more in the lower gastrointestinal tract, the effectiveness and safety of Nexpowder as an endoscopic hemostatic treatment are confirmed.
Read the detailed description
Total number of target subjects 66 Test group 33 / Control group: 33 If endoscopic polypectomy is performed on polyps of 2cm or more, the probability of bleeding as a complication is 6.5%. This clinical study is an observational study to confirm the safety and effectiveness of Nexpowder, an endoscopic hemostatic powder after colonoscopy polypectomy, and an exploratory evaluation of 60 patients is conducted.
- Conditions
- GastroIntestinal Bleeding
- Being tested
- Nexpowder, Conventional Treatment
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexpowderDevice
Hemostatic powder for endoscopy after colonoscopy polypectomy
Conventional TreatmentProcedure or surgery
Standard hemostatic procedure
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Conventional Treatment Receives: Procedure: Conventional Treatment |
| Conventional Treatment + Nexpowder | Experimental | Conventional Treatment + Nexpowder Receives: Device: Nexpowder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rebleeding within 7 days of successful endoscopic hemostasis
Rate of rebleeding within 7 days of successful endoscopic hemostasis
Measured: 7 days
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Measured: 30 days
Secondary outcomes (8)
Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group
Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group
Measured: 5 min
Perforation incidence
Perforation incidence
Measured: 7 days
Death rate
Death rate
Measured: 7 days
Blood transfusion case rate
Blood transfusion case rate
Measured: 7 days
Number of Nexpowder applications (experimental group)
Number of Nexpowder applications (experimental group)
Measured: 7 days
Number of usage of Nexpowder (experimental group)
Number of usage of Nexpowder (experimental group)
Measured: 7 days
Incidence of device malfunction (experimental group)
Incidence of device malfunction (experimental group)
Measured: 7 days
Rate of ease of use (experimental group)
Rate of ease of use (experimental group)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start18 Oct 2022
- Primary completion1 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kibae Kim, Ph.D., Study director, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884931
- Sponsor's protocol ID
- Nexpowder_02
- Status last verified
- Feb 2024
- First submitted
- 8 May 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No