Targeted Renal Therapy
Conditions
Keywords
FlowMedica, Benephit, TRT, Patients, Components, Benephit Infusion System, Planned, To be used
Brief summary
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: 1. Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents. 2. Collect user-interface information and overall customer satisfaction. 3. Monitor post-marketing device performance.
Interventions
DEVICETargeted Renal Therapy
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.
Sponsors
FlowMedica, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Exposure to one or more components of the Benephit Infusion System * Ability to give written informed consent
Exclusion criteria
* Inclusion in another clinical study that may affect usage of the Benephit system
Countries
United States
Outcome results
None listed