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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02241044 |
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Date of registration:
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11/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Argon Plasma Coagulation for Bleeding Peptic Ulcers
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Scientific title:
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Ivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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116 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02241044 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Huay-Min Wang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- (i) over 20 years of age and (ii) patients with high-risk peptic ulcer bleeding.
Exclusion Criteria:
- (i) the presence of another possible bleeding site (eg, gastroesophageal varix,
gastric cancer, reflux esophagitis); (ii) coexistence of actively severe ill diseases
(eg, septic shock, stroke, myocardial infarction, surgical abdomen); (iii) treatment
with an anticoagulant (eg, warfarin); (iv) pregnancy; (v) the presence of operated
stomach or; (vi) refusal to participate in the study.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bleeding Ulcers
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Intervention(s)
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Device: Distilled water
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Device: Argon plasma coagulation
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Primary Outcome(s)
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rebleeding
[Time Frame: up to 30 days]
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Secondary Outcome(s)
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Surgery
[Time Frame: up to 30 days]
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mortality
[Time Frame: up to 30 days]
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sever adverse events
[Time Frame: up to 30 days]
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Secondary ID(s)
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VGHKS98-CT8-13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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