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

ESRD Clinical Trial

— LTHD PMCF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04782297
• Other study ID #: PMCF_LTHD_201
• Status: Withdrawn
• Start date: March 30, 2022
• Est. completion date: March 17, 2023

Study information

• Verified date: January 2024
• Source: Medical Components, Inc dba MedComp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age at the time of enrollment

2. 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

3. 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)

4. Subject or authorized representative participated in the Informed Consent process and signed/dated the relevant institutional ethics committee approved Informed Consent form

Exclusion Criteria:

1. Meet any of the contraindications listed on the Medcomp Long Term Hemodialysis Catheter Instructions for Use

2. 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)

Related Conditions & MeSH terms

• CKD
• ESRD

Intervention

Device:
• Long term hemodialysis catheter
There will be no interventions in this study. Strictly observational.

Locations

Country	Name	City	State
Spain	Hospital Universitari Arnau de Vilanova	Lleida
United States	University of Maryland School of Medicine Vascular & Interventional Radiology Department	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Medical Components, Inc dba MedComp	Syneos Health, Veeva Systems

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion Success	Successful initiation of vascular access device insertion, as determined by the investigator.	Percentage at Insertion
Secondary	Adverse Events (Infection per 1000 catheter days)	Infection, Removals due to infection or thrombosis, catheter related blood stream infection (CRBSI)	1000 catheter days