Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
This study has been completed.
Sponsor:
Polyak, Maximilian
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by:
Polyak, Maximilian
ClinicalTrials.gov Identifier:
NCT00879268
First received: April 7, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | April 7, 2009 | ||||
| Last Updated Date | April 7, 2009 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System | ||||
| Official Title ICMJE | Phase 1 Study of Liver Machine Preservation With Vasosol Solution | ||||
| Brief Summary | This is a pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
Utilization of Vasosol with Medtronic System for Machine Preservation of the Liver for Liver Transplantation
Other Names:
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| Study Arm (s) | |||||
| Publications * | |||||
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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 | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00879268 | ||||
| Other Study ID Numbers ICMJE | G030132 | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | Dr. James V. Guarrera, Columbia University Medical Center | ||||
| Study Sponsor ICMJE | Polyak, Maximilian | ||||
| Collaborators ICMJE | Health Resources and Services Administration (HRSA) | ||||
| Investigators ICMJE |
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| Information Provided By | Polyak, Maximilian | ||||
| Verification Date | April 2009 | ||||
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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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