Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00716404
Status:
WITHDRAWN
Last Update Posted:
2010-02-05
First Post:
2008-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Market Observational Study of Intra-Renal Drug Delivery
Sponsor:
FlowMedica, Inc.
Organization:
Study Overview
Official Title:
Post-Market Observational Study of Intra-Renal Drug Delivery
Status:
WITHDRAWN
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FlowMedica was purchased by AngioDynamics. Study will be re-started by AngioDynamics.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVIDE
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: