Safety and Performance Study of the CardioGard Cannula
This study is currently recruiting participants.
Verified March 2012 by CardioGard Medical Ltd.
Sponsor:
CardioGard Medical Ltd.
Information provided by (Responsible Party):
CardioGard Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01554709
First received: March 11, 2012
Last updated: March 13, 2012
Last verified: March 2012
| Tracking Information | |||||
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| First Received Date ICMJE | March 11, 2012 | ||||
| Last Updated Date | March 13, 2012 | ||||
| Start Date ICMJE | March 2012 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
DWI- Diffusion Weighted Imaging [ Time Frame: The outcome measure is assessed in average a week after the surgery ] [ Designated as safety issue: No ] diffusion weighted magnetic resonance imaging (DW-MRI) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01554709 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
TCD- Transcranial Doppler [ Time Frame: The Outcome measure is assessed during the surgery ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Performance Study of the CardioGard Cannula | ||||
| Official Title ICMJE | A Study to Collect Additional Information Related to the Safety and Performance of the CardioGard Cannula | ||||
| Brief Summary | The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Aortic Valve Replacement | ||||
| Intervention ICMJE | Device: Aortic Cannulas (CardioGard)
Comparison of aortic cannulas during by pass surgery |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Germany, Israel, Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01554709 | ||||
| Other Study ID Numbers ICMJE | CLN0009 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | CardioGard Medical Ltd. | ||||
| Study Sponsor ICMJE | CardioGard Medical Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | CardioGard Medical Ltd. | ||||
| Verification Date | March 2012 | ||||
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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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