Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)
NCT04782297 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2024-01-10
Summary
The primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745.
Conditions
- CKD
- ESRD
Interventions
- DEVICE
-
Long term hemodialysis catheter
There will be no interventions in this study. Strictly observational.
Sponsors & Collaborators
- collaborator OTHER
-
Veeva Systems
collaborator INDUSTRY -
Medical Components, Inc dba MedComp
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-30
- Primary Completion
- 2023-03-17
- Completion
- 2023-03-17
- FDA Device
- Yes
Countries
- United States
- Spain
Study Locations
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