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Clinical Trials/NCT02899780
NCT02899780WithdrawnNot Applicable

Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

Ultraviolet Interventions2 sites in 1 countryStarted: May 11, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Be at least 18 years of age
  • •Have the ability to provide informed consent
  • •Have an implanted dialysis catheter of one of the following models: Medcomp Titan 15.5F x 24 cm or Medcomp Titan 15.5F x 28 cm
  • •Positive blood culture drawn from the catheter

Exclusion Criteria

  • •Previous inclusion in study

Arms & Interventions

Ultraviolet arm

Experimental

This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber.

Intervention: Ultraviolet light emitting optical fiber (Device)

Outcomes

Primary Outcomes

Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter

Time Frame: Measured immediately after UV treatment

Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter

Time Frame: Measured at study end, expected at 1 year.

Secondary Outcomes

  • Number of colony forming units (CFU) per cm2 of surface area on the inner lumen of removed catheters(Measured after UV treatment, with results expected in 5 days.)
  • Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage.(Measured at study end, expected at 1 year.)

Investigators

Sponsor
Ultraviolet Interventions
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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