Clinical trial NCT04782297: Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: CKD
ESRD
Lead sponsor: Medical Components, Inc dba MedComp
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: Veeva Systems
First posted: 2021-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective patients (those who already have one of the Medcomp LTHD catheters inserted) will be enrolled. Retrospective patients from the previous 36 months will be approached for participation in the study. Patients who have previously received a Medcomp LTHD catheter will also be approached for consent and assessment of eligibility.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Insertion Success
timeFrame: Percentage at Insertion
Secondary outcomes:
measure: Adverse Events (Infection per 1000 catheter days)
timeFrame: 1000 catheter days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine Vascular & Interventional Radiology Department
state: Maryland
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
Study officials:
References: