Post-Market Observational Study of Intra-Renal Drug Delivery (PROVIDE)

FlowMedica

Status: Withdrawn

Conditions: Targeted Renal Therapy

Treatments: Device: Targeted Renal Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT00716404

CL0015

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

1

Description:

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.

Treatment:

Device: Targeted Renal Therapy