Status:
WITHDRAWN
Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)
Lead Sponsor:
Medical Components, Inc dba MedComp
Collaborating Sponsors:
Syneos Health
Veeva Systems
Conditions:
CKD
ESRD
Eligibility:
All Genders
18+ years
Brief 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 wi...
Eligibility Criteria
Inclusion
- ≥ 18 years of age at the time of enrollment
- Patients who have previously received the Medcomp subject device or patients currently receiving hemodialysis treatment, who have had a Medcomp subject device implanted for \>90 days
- Health records relevant to this study are complete and accessible by Study team at the hemodialysis center, implantation center, medical facilities where complications are treated, and by the participating Principal Investigator (PI)
- Subject or authorized representative participated in the Informed Consent process and signed/dated the relevant institutional ethics committee approved Informed Consent form
Exclusion
- Meet any of the contraindications listed on the Medcomp Long Term Hemodialysis Catheter Instructions for Use
- Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Study in the opinion of the sponsor in consultation with the Principal Investigator)
Key Trial Info
Start Date :
March 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 17 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04782297
Start Date
March 30 2022
End Date
March 17 2023
Last Update
January 10 2024
Active Locations (2)
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1
University of Maryland School of Medicine Vascular & Interventional Radiology Department
Baltimore, Maryland, United States, 21202
2
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198