Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

October 27, 2018 updated by: Ultraviolet Interventions
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultraviolet arm
This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber.
Device: Ultraviolet light emitting optical fiber
A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.
Other Names:
  • Lumenati Fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Time Frame: Measured immediately after UV treatment
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.
Measured at study end, expected at 1 year.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ultraviolet Interventions

Collaborators

University of Maryland

Investigators

  • Principal Investigator: Nabeel Akhter, MD, University of Maryland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2017

Primary Completion (Actual)

May 10, 2018

Study Completion (Actual)

May 10, 2018

Study Registration Dates

First Submitted

August 27, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 27, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVI-Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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