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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01139424 |
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Date of registration:
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28/05/2010 |
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Primary sponsor: |
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Public title:
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Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing
GASTROSUTURE |
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Scientific title:
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Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01139424 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Annette Fritscher-Ravens, MD |
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Address:
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Telephone:
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0049-431-597-2133 |
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Email:
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fritscher-ravens@1med.uni-kiel.de |
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Affiliation:
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Name:
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Annette Fritscher-Ravens, MD |
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Address:
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Telephone:
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0049-431-597-2133 |
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Email:
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Affiliation:
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Name:
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Annette Fritscher-Ravens, 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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UKSH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection
Exclusion Criteria:
- tubular ischemia of the upper GI tract
- inability to provide informed consent
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anastomosis, Surgical
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Postoperative
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Intervention(s)
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Device: endoscopic suturing
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Primary Outcome(s)
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Safety
[Time Frame: 2 years]
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Technical feasibility
[Time Frame: 2 years]
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Secondary Outcome(s)
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Long term safety
[Time Frame: 6 months after diagnosis of anastomotic leakage]
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Time to healing of the anastomotic leak
[Time Frame: 2 years]
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Secondary ID(s)
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1-Fritscher-Ravens
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UKSH1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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