NCT04841226

Brief Summary

To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce biofilm formation in subjects that require a long-term indwelling Foley catheter when compared to other commercially available urinary catheters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

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

April 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

December 28, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

April 7, 2021

Last Update Submit

November 26, 2024

Conditions

Biofilm FormationUTI

Keywords

Urinary CatheterFoley

Outcome Measures

Primary Outcomes (1)

  • Biofilm formation

    A core lab will use the BacTiter-Glo Microbial Cell Viability Assay, a well characterized method for quantifying active biomass and biofilm, to determine biofilm formation on explanted catheter samples.

    5 to 7 days

Study Arms (3)

Silq ClearTract™ 100% Silicone 2-Way Foley Catheter

ACTIVE COMPARATOR

Up to 82 subjects

Device: Long-term indwelling Foley catheter

Silver-coated Latex 2-Way Foley Catheter

ACTIVE COMPARATOR

Up to 82 subjects

Device: Long-term indwelling Foley catheter

Silicone-coated Latex 2-Way Foley catheter

ACTIVE COMPARATOR

Up to 82 subjects

Device: Long-term indwelling Foley catheter

Interventions

Long-term indwelling Foley catheterDEVICE

Foley Catheter inserted for up to 28-days

Silicone-coated Latex 2-Way Foley catheterSilq ClearTract™ 100% Silicone 2-Way Foley CatheterSilver-coated Latex 2-Way Foley Catheter

Eligibility Criteria

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

You may qualify if:

  • Male or female age ≥ 18 years old;
  • Requiring indwelling 16Fr Foley catheter for at least 7 days;
  • Able and willing to comply with study procedure; and,
  • Able and willing to give informed consent.

You may not qualify if:

  • Allergy or sensitivity to any catheter materials used in this study;
  • Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheter;
  • Planned Prophylactic use of antibiotics for CAUTI or any other infection beyond day 1 of the study (catheter implantation);
  • Symptomatic UTI being treated with antibiotics (as determined by the study PI, including at least one of the following: fever, chills, headache, burning sensation, burning of urethra or genital area, blood in urine, foul smelling urine and ≥ 10,000 cfu/mL);
  • Any other infection being treated with antibiotics at the time of catheter implantation;
  • Subjects requiring bladder irrigation during the study (an active voiding trial in surgical subjects prior to catheter removal is allowed);
  • Currently enrolled in another interventional clinical trial;
  • Any other condition that, in the opinion of the investigator, precludes study participation or poses a significant hazard in case of study participation; and
  • Females who are pregnant or breastfeeding or who plan to become pregnant during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Urology Associates of Southern Arizona

Tucson, Arizona, 85715, United States

Location

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

Location

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

Location

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Evergreen Health

Kirkland, Washington, 98034, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 12, 2021

Study Start

December 28, 2021

Primary Completion

March 31, 2024

Study Completion

August 15, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

US(8)