Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0009050
- Lead Sponsor
- extbiomedical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 352
1.Males or females of Age of 19 (Nineteen) or Older
(In case of Age of 75 (Seventy-Five) or older or if patient falls under emergencycondition, a written consent from the patient's guardian or legal representativeis required)
2.Indication of non-variceal upper gastrointestinal bleeding.
3.Forrest scores Ia, Ib or IIa by endoscopy findings
(Patients with class IIb or adherent clot, were reevaluated for class Ia, Ib or IIa after intensive irrigation procedure was performed to remove the clot)
4.Subjects who voluntarily agreed to the clinical trial and who were willing toand could comply with the study protocol
1.Patients, who are unable to receive endoscopic treatment due to comorbidity
2.The 30-day follow-up is not possible.
3.Patients who are going through Pregnancy or breastfeeding
4.Endoscopic treatment is prohibited because of comorbidity
5.Patients who participated in the related clinical trials that can affect the studyresults within the past month
6.Other cases in which participation in the study is not appropriate by thejudgment of the investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For comparison of the test and study group, the rate of rebleeding over the three (3)days following initial hemostasis is evaluated to be lower in the test groupthan in the control group with statistical significance
- Secondary Outcome Measures
Name Time Method For Test Group: 1)Ease of use of Nexpowder™ device 2)Any occurrence of device malfunction from the use of Nexpowder™ For Test and Control Group: 3)Safety monitoring observations conducted over 30-day period followinginitial hemostatic success to monitor occurrence of safety incidents or adverseevents