Evaluation of Quality-of-Life Improvements Using UroShiel... | NCT06319352

Studies
Evaluation of Quality-of-Life Improvements Using UroShield Device

NCT06319352

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Nov 29, 2024Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Quality of Life
Catheter-Associated Urinary Tract Infection

Interventions

Active UroShield
Sham UroShield

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2024Actual

Primary Completion Date

Oct 18, 2024Actual

Completion Date

Nov 1, 2024Actual

First Submitted Date

Mar 12, 2024

First Submission Date that Met QC Criteria

Mar 12, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2024

Last Update Posted Date

Nov 29, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lona Mody, Principal Investigator, Professor of Internal Medicine, University of MichiganPrincipal Investigator

Lead Sponsor

University of MichiganOTHER

Collaborators

Name	Class
Nanovibronix	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.

The main questions the investigators aim to answer focus on implementation and practicality:

Recruitment feasibility and time to recruit
How well do participants adhere to device protocol?
How often do device components (i.e., actuators and drivers) have to be replaced?
How much time is required for data collection and what sources or methods for data collection are used?

Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow.

Detailed Description

The UroShield® device works by generating ultrasonic waves to interfere with attachment of bacteria inside the catheter, preventing biofilm formation and subsequent infections.

This double-blind pilot study aims to recruit 10-20 patients with urinary catheters (urethral or suprapubic catheters) living in nursing homes (NHs) in Michigan. Patients who consent to participate in the study will be randomized to either the treatment or control group and will have either an active treatment UroShield® device attached or a sham UroShield® device attached to the external tubing of their urinary catheter. Participants will wear the device continuously for a maximum of 90 days. Assessments of pain and quality-of-life will be conducted by study staff over a maximum of 6 study visits, along with clinical data collection via medical record review. A urine sample and catheter sample will also be collected by study staff at each catheter change (approximately every 30 days).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active UroShield	Experimental	Active UroShield Device	Device: Active UroShield
Sham UroShield	Sham Comparator	Inactive UroShield device	Device: Sham UroShield

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active UroShield	Device	Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.	Active UroShield

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recruitment rate	Number of patients enrolled out of number of patients eligible to participate in the study.	Summarized every month for 6 months, or until the recruitment goal is reached.

Secondary Outcomes

Measure	Description	Time Frame
Device use adherence	Number of patients with at least 80% adherence out of total patients enrolled. Device adherence will be assessed via direct observation by study staff as well as patient/caregiver/clinician-reported (via written documentation or phone/email correspondence).	Summarized every month for at least 6 months, or until the recruitment goal is reached.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female age 18+
Indwelling urinary catheter (urethral or suprapubic) in place
Written informed consent (and assent, when applicable) obtained from participant or participant's legal representative
Able to comply with the requirements of the study

Exclusion Criteria:

Pregnant or breastfeeding women
Antibiotic use in past 10 days
Ineligible catheter type in place (e.g., antimicrobial coated, 3-way catheter, condom catheter, nephrostomy tube, wicking device)
Participation in another drug or device study in past 30 days
History of poor compliance to medical treatment regimens
Conditions that may severely compromise their ability to complete the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lona Mody	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evangelical Home - Saline		Saline	Michigan	48176	United States