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Evaluation of Quality-of-Life Improvements Using UroShield Device

NCT06319352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-11-29

No results posted yet for this study

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.

Conditions

  • Quality of Life
  • Catheter-Associated Urinary Tract Infection

Interventions

DEVICE

Active UroShield

Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.

DEVICE

Sham UroShield

Participants will have an inactive device (i.e., no ultrasound energy being produced by the actuator) attached to their urinary catheter tube. All other aspects of the sham device (look, weight, feel, sound, and operation) are identical to the active device.

Sponsors & Collaborators

Principal Investigators

  • Lona Mody · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2024-10-18
Completion
2024-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319352 on ClinicalTrials.gov