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| Name | Class |
|---|---|
| Keimyung University Dongsan Medical Center | OTHER |
| Korea University Anam Hospital | OTHER |
| National Cancer Center, Korea | OTHER_GOV |
| Nowon Eulji Medical Center |
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We are going to conduct a comparative study to analyze the clinical effectiveness and user convenience of EZ clips that have been used in upper gastrointestinal ulcer bleeding and newly developed clip (ClearEndoclip, FineMedix, Taegu) in Korea.
1) Research hypothesis and purpose
Design of this study
Patients and Methods
inclusion criteria
exclusion criteria
The number of patients
The number of subjects was calculated based on a non-inferiority study
The reported rate of rebleeding after hemostasis using the conventional hemoclip: about 5%.
2.5% one-sided test, 80% power, and non-inferiority limit set to 10%
Methods
Variables to be collected
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClearEndoclip | Experimental | This arm is a group in whom ClearEndoclip would be used for the treatment of bleeding. |
|
| EZ clip | Active Comparator | This arm is a group in whom EZ clip would be used for the treatment of bleeding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic hemostasis with clip | Device | This intervention is performed as the following orders.
|
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding rate after endoscopic hemostasis | The rate of rebleeding at the site of bleeding within 7 days after the first endoscopic hemostasis, which should be identified endoscopically. | upto 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction scores of the operator and the assistant | the degree in ten-scale in terms of an endoscopic visibility to a bleeding site and the easiness of use. the minimum: 1(worst value), the maximum: 10(best) | during endoscopic procedure |
| Failure rate of clip installation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Gyo Lim | Department of Gastroenterology, Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Gyo Lim | Suwon | Gyeonggi-do | 16499 | South Korea |
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| ID | Term |
|---|---|
| D010438 | Peptic Ulcer Hemorrhage |
| D010437 | Peptic Ulcer |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D016558 | Hemostasis, Endoscopic |
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| OTHER |
| Pusan National University Hospital | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Inha University Hospital | OTHER |
| Presbyterian medical center | UNKNOWN |
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|
Ratio of unsuccessful clips to total number of clips used |
| during endoscopic procedure |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |