Non-variceal Upper Gastrointestinal BleedingNCT02054260
Surgicel® (Fibrillar) in Non-variceal UGI Bleeding
A study testing Surgicel in people with Non-variceal Upper Gastrointestinal Bleeding, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-variceal Upper Gastrointestinal Bleeding
- What is being tested?
- Surgicel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento Dec 2015
- 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 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy
- Patients with active bleeding (Forrest classification Ia or Ib or IIa)
Who cannot join
- Patients with upper gastrointestinal tract malignancy
- Patients with acute severe illness
- Coagulopathy: liver cirrhosis, thrombocytopenia
- Pregnant women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine
Bucheon-si, 420-767
Su Jin Hong, MD, PhD, +82-32-621-5087, sjhong@schmc.ac.kr
About this study
The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding
- Being tested
- Surgicel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgicelDrug
| Study group | Role | What they receive |
|---|---|---|
| Surgicel add therapy | Experimental | Not described Receives: Drug: Surgicel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate at the second look endoscopy
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-variceal 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
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Jin Hong, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054260
- Sponsor's protocol ID
- SCHBC_IRB_2013-40
- Status last verified
- Nov 2014
- First submitted
- 3 Feb 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgicel® (Fibrillar) in Non-variceal UGI Bleeding
- ClinicalTrials.gov ID
- NCT02054260
- Acronym / sponsor ID
- SCHBC_IRB_2013-40
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Primary completion
- Dec 2015 (estimated)
- First posted
- 4 Feb 2014 (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.
The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgicel add therapy | Experimental | Drug: Surgicel |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy
- Patients with active bleeding (Forrest classification Ia or Ib or IIa)
Key exclusion criteria (4 listed)
- Patients with upper gastrointestinal tract malignancy
- Patients with acute severe illness
- Coagulopathy: liver cirrhosis, thrombocytopenia
- Pregnant women
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 |
|---|---|---|
| Surgicel | Drug | Surgicel add therapy |
Primary outcome
Rebleeding rate at the second look endoscopy
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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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 Surgicel in people with Non-variceal Upper Gastrointestinal Bleeding, run by Soonchunhyang University Hospital at 1 site 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 4 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 19 Nov 2014. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Jin Hong, MD, PhD (+82-32-621-5087, sjhong@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding rate at the second look endoscopy (time frame: 2 year). 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 19 Nov 2014; AzTrials last refreshed its copy on 26 Oct 2026.