NCT04782297

Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)

Post-Market Clinical Follow-up Study - Open Label, Consecutive Series, Observational Study on the Use of Medcomp Long Term Catheters for Hemodialysis (LTHD)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medical Components, Inc dba MedComp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Observational Study will enroll a target of 198 subjects across two cohorts of 89 patients per cohort, with each cohort representing one catheter type. Retrospective patients previously treated with either a Hemo-Flow or Titan HD catheter will be enrolled. The primary endpoint of this study for all device families is insertion success. For the purposes of this data, a successful insertion will be defined as the successful initiation of vascular access device insertion, as determined by the investigator.

Conditions

• CKD
• ESRD

Interventions

Type	Name	Description
DEVICE	Long term hemodialysis catheter	There will be no interventions in this study. Strictly observational.

Timeline

• Start date: 2022-03-30
• Primary completion: 2023-03-17
• Completion: 2023-03-17
• First posted: 2021-03-04
• Last updated: 2024-01-10

Locations

2 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study