Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

NCT ID: NCT02899780

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2018-05-10

Brief Summary

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

Detailed Description

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Conditions

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Catheter-Related Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultraviolet arm

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

Group Type EXPERIMENTAL

Ultraviolet light emitting optical fiber

Intervention Type DEVICE

A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.

Interventions

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Ultraviolet light emitting optical fiber

A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.

Intervention Type DEVICE

Other Intervention Names

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Lumenati Fiber

Eligibility Criteria

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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
* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland

OTHER

Sponsor Role collaborator

Ultraviolet Interventions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nabeel Akhter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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UVI-Pilot

Identifier Type: -

Identifier Source: org_study_id

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