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FlowMedica was purchased by AngioDynamics. Study will be re-started by AngioDynamics.
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This is a prospective, observational, multi-center study with consecutive enrollment. Up to 1,000 patients will be enrolled. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, FlowMedica will be able to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | All (consecutive) patients in whom one or more components of the Benephit Infusion System are planned to be used are eligible for enrollment in the study and should be offered informed consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Renal Therapy | Device | Patient diagnosis, treatment, and follow-up are left to the discretion of the participating investigator. There are no requisites as to how patients should be managed as this is intended to be an observational study. No procedures other than usage of the Benephit Infusion System per its Instructions for Use are specifically required for participation in this study. |
Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients in whom one or more components of the Benephit Infusion System are planned to be used.
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| Name | Affiliation | Role |
|---|---|---|
| James A Tumlin, MD | Southeast Renal Associates | Principal Investigator |
| David E Allie, MD | Cardiovascular Institute of the South | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | United States | ||
| Owensboro Heart & Vascular |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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|
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| Owensboro |
| Kentucky |
| 42303 |
| United States |
| Cardiovascular Institute of the South | Lafayette | Louisiana | 70506 | United States |
| Providence Heart & Vascular | Portland | Oregon | 97225 | United States |