Upper Gastrointestinal BleedingNCT02978391
UI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD
A study testing UI-EWD Hemostatic system and epinephrine endoscopic injection (conventional therapy) in people with Upper Gastrointestinal Bleeding, run by Next Biomedical Co., Ltd. at 2 sites in South Korea.
Trial summary
UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- UI-EWD Hemostatic system and epinephrine endoscopic injection (conventional therapy)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 May 2016to 18 Sep 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of bleeding peptic ulcer and active bleeding after ESD/EMR
Who cannot join
- Coagulation disorder (PLT < 50*10^9/L, INR > 2)
- Connot stop taking the antiplatelet drug, NSAID, Anticoagulant drug, and Aspirin during endoscopic treatment and after 72h endoscopy
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Soonchunhyang University College of Medicine
Bucheon-si, 14584
Inha University Hospital
Incheon, 22332
About this study
Official title: A Prospective, Multicenter, Single-blind, Controlled Clinical Trial to Confirm the Efficacy and Safety of 'UI-EWD', a Wound Dressing Used for Wound Protection and Hemostasis After Ulcer Bleeding Due to Peptic Ulcer, EMR and ESD
UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.
Read the detailed description
UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. This study has been designed to observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- UI-EWD Hemostatic system, epinephrine endoscopic injection (conventional therapy)
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UI-EWD Hemostatic systemDevice
Adhesive endoscopic hemostats, powder type
epinephrine endoscopic injection (conventional therapy)Drug
endoscopic submucosal injection of epinephrine (1: 10,000)
| Study group | Role | What they receive |
|---|---|---|
| UI-EWD Hemostatic system | Experimental | Patients with upper gastrointestinal bleeding treated with UI-EWD Receives: Device: UI-EWD Hemostatic system |
| epinephrine | Active comparator | Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection Receives: Drug: epinephrine endoscopic injection (conventional therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent bleeding rate
Rebleeding rate up to 3 days was obtained by clinical manifestations such as melana; decreased hemoglobin > 2g/dL; hemodynamic instability or active bleeding from mucosal defect under endoscope.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start23 May 2016
- Primary completion30 Nov 2016
- Study completion18 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong-Woon Shin, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978391
- Sponsor's protocol ID
- NEXTBIO-631-EWD3
- Status last verified
- Sep 2017
- First submitted
- 23 Nov 2016
- Last updated
- 8 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-blind, Controlled Clinical Trial to Confirm the Efficacy and Safety of 'UI-EWD', a Wound Dressing Used for Wound Protection and Hemostasis After Ulcer Bleeding Due to Peptic Ulcer, EMR and ESD
- ClinicalTrials.gov ID
- NCT02978391
- Acronym / sponsor ID
- NEXTBIO-631-EWD3
- Conditions
- Upper Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Next Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 30 Nov 2016 (estimated)
- 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.
UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.
Detailed description
UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. This study has been designed to observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI-EWD Hemostatic system | Experimental | Device: UI-EWD Hemostatic systemPatients with upper gastrointestinal bleeding treated with UI-EWD |
| epinephrine | Active comparator | Drug: epinephrine endoscopic injection (conventional therapy)Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of bleeding peptic ulcer and active bleeding after ESD/EMR
Key exclusion criteria (2 listed)
- Coagulation disorder (PLT < 50*10^9/L, INR > 2)
- Connot stop taking the antiplatelet drug, NSAID, Anticoagulant drug, and Aspirin during endoscopic treatment and after 72h endoscopy
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 |
|---|---|---|
| UI-EWD Hemostatic systemAdhesive endoscopic hemostats, powder type | Device | UI-EWD Hemostatic system |
| epinephrine endoscopic injection (conventional therapy)endoscopic submucosal injection of epinephrine (1: 10,000) | Drug | epinephrine |
Primary outcome
Recurrent bleeding rate
Time frame: 3 days
Rebleeding rate up to 3 days was obtained by clinical manifestations such as melana; decreased hemoglobin > 2g/dL; hemodynamic instability or active bleeding from mucosal defect under endoscope.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
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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.
Yong-Woon Shin principal investigator
Inha University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UI-EWD Hemostatic system and epinephrine endoscopic injection (conventional therapy) in people with Upper Gastrointestinal Bleeding, run by Next Biomedical Co., Ltd. at 2 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrent bleeding rate (time frame: 3 days). 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 8 Apr 2022.