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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: |
NCT00876551 |
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Date of registration:
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03/04/2009 |
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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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Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
EVACoIL |
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Scientific title:
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Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00876551 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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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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Jochen Wedemeyer, MD |
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Address:
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Telephone:
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+49 511 532 |
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Email:
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wedemeyer.jochen@mh-hannover.de |
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Affiliation:
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Name:
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Jochen Wedemeyer, MD |
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Address:
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Telephone:
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+49 511 532 |
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Email:
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wedemeyer.jochen@mh-hannover.de |
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Affiliation:
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Name:
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Jochen Wedemeyer, 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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Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients at the Medical School Hannover that present with intrathoracic
postsurgical leakage that can be intubated with a regular 9.2mm diameter endoscope
(Olympus GIF-165, Olympus
- Age over 18 years old
- Signed informed consent
Exclusion Criteria:
- Small leakage that can be treated with clips
- Refusal to participate in study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mediastinitis
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Esophageal Neoplasms
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Anastomotic Leakage
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Intervention(s)
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Procedure: Endoscopic vacuum assisted closure
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Primary Outcome(s)
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Closure of postsurgical leak
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Short term complications
[Time Frame: 6 weeks]
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Long term complications
[Time Frame: 6 months]
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C reactive protein
[Time Frame: 6 weeks]
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number of endoscopic interventions
[Time Frame: 6 weeks]
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time to leak closure
[Time Frame: 6 weeks]
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Secondary ID(s)
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Spongebop01
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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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