NCT02899780

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

August 27, 2016

Last Update Submit

October 27, 2018

Conditions

Catheter-Related Infections

Outcome Measures

Primary Outcomes (2)

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

    Measured immediately after UV treatment

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

    Measured at study end, expected at 1 year.

Secondary Outcomes (2)

  • 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.

Study Arms (1)

Ultraviolet arm

EXPERIMENTAL

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

Device: Ultraviolet light emitting optical fiber

Interventions

Ultraviolet light emitting optical fiberDEVICE

A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.

Also known as: Lumenati Fiber
Ultraviolet arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Nabeel Akhter, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 14, 2016

Study Start

May 11, 2017

Primary Completion

May 10, 2018

Study Completion

May 10, 2018

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)