Post-Market Observational Study of Intra-Renal Drug Delivery
NCT ID: NCT00716404
Last Updated: 2010-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
1000 participants
OBSERVATIONAL
2008-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
NCT04608149
Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
NCT00633308
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension
NCT01749761
Clinical Evaluation of the CM-1500 During Hemodialysis
NCT05125848
Evaluation of Amlodipine Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis
NCT03722381
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Targeted 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Targeted 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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to give written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
FlowMedica, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AngioDynamics, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James A Tumlin, MD
Role: PRINCIPAL_INVESTIGATOR
Southeast Renal Associates
David E Allie, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Institute of the South
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scripps Clinic
La Jolla, California, United States
Owensboro Heart & Vascular
Owensboro, Kentucky, United States
Cardiovascular Institute of the South
Lafayette, Louisiana, United States
Providence Heart & Vascular
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CL0015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.