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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | January 8, 2007 | ||||
| Start Date ICMJE | March 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
To evaluate the performances of the WE-CT in patients suspected of having a colon tumor | ||||
| Original Primary Outcome Measures ICMJE |
To evaluate the performances of the WE-CT in patients suspected of colon tumor | ||||
| Change History | Complete list of historical versions of study NCT00188110 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Performance of the Water-Enema Computed Tomography (WE-CT) | ||||
| Official Title ICMJE | Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor | ||||
| Brief Summary | The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen. The goal of the study is the evaluation of its performances for the diagnosis of colon tumors. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Non-Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Colon Cancer | ||||
| Intervention ICMJE | Procedure: Water-Enema Computed Tomography | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00188110 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | PHRC-02-01, 2002/23 (CCPPRB) | ||||
| Study Sponsor ICMJE | University Hospital, Angers | ||||
| Collaborators ICMJE | Ministry of Health, France | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Angers | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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