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DuraLock-C Catheter Lock Solution

NCT04787926 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2024-01-10

No results posted yet for this study

Summary

To evaluate the safety and performance of DuraLock-C 4.0%, 30.0%, and 46.7% for the maintenance of central venous catheter (CVC) patency in adult hemodialysis (HD) patients

Conditions

  • Catheter-Related Infections
  • Citrate Adverse Reaction

Interventions

DEVICE

Locking Solution

The total duration of the study treatment period will be 90 calendar days, from Visit 1 Pre-Instillation to the last study-related assessment. Two to 3 instillations (1 per lumen per visit) of DuraLock-C 4.0%, 30.0%, or 46.7% (equivalent to the catheter manufacturer's prescribed priming volume) will be instilled 1 to 3 days apart (with a HD schedule of 3 to 4 times per week); each instillation of CLS will remain in the CVC for approximately 24 to 72 hours ± 12 hours, based on their practice preferences. EOS will take place at the patient's next scheduled dialysis session.

Sponsors & Collaborators

  • Syneos Health

    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
2021-09-23
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787926 on ClinicalTrials.gov