Butterfly portable ultrasound device with bladder ultrasound images for Voiding Dysfunction

Phase-Based Progress Estimates

Effectiveness

Safety

Yale New Haven Hospital, New Haven, CT

Voiding Dysfunction+1 More

Butterfly portable ultrasound device with bladder ultrasound images - Device

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

Patient Self Measurement of Post-Void Residual Bladder Volume (PVR) Using Ultrasound

See full description

Eligible Conditions

Voiding Dysfunction
Voiding Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Voiding Dysfunction

Butterfly iQ+ ultrasound probe

Focused ultrasound

"Neo-Bladder" Construct

Study Objectives

This trial is evaluating whether Butterfly portable ultrasound device with bladder ultrasound images will improve 5 primary outcomes and 1 secondary outcome in patients with Voiding Dysfunction. Measurement will happen over the course of up to 6 months.

up to 6 months

Accuracy of patient self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's bladder catheterization of the patient measured by Bland-Altman analysis.

Accuracy of patient self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the existing ultrasound technology measured by Bland-Altman analysis.

Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the Butterfly with abstract bladder images measured by Bland-Altman analysis.

Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly with abstract bladder images measured by Bland-Altman analysis.

Accuracy of self-measurement of PVR using the Butterfly with bladder ultrasound images compared to the healthcare provider's measurements of patient PVR using the Butterfly with bladder ultrasound images measured by Bland-Altman analysis.

Patient Reported Outcomes Questionnaire to asses ease of use, satisfaction, and preference of Butterfly Device

Trial Safety

Safety Progress

1 of 3

Other trials for Voiding Dysfunction

Butterfly iQ+ ultrasound probe

Focused ultrasound

"Neo-Bladder" Construct

Trial Design

5 Treatment Groups

Healthcare provider performed standard PVR measurement using existing ultrasound...

1 of 5

Healthcare provider performed PVR measurement using Butterfly and bladder ultras...

1 of 5

Self PVR measurement using Butterfly and bladder ultrasound images

1 of 5

Self PVR measurement using Butterfly and abstract bladder images

1 of 5

Healthcare provider performed PVR measurement using Butterfly and abstract bladd...

1 of 5

Active Control

Experimental Treatment

This trial requires 50 total participants across 5 different treatment groups

This trial involves 5 different treatments. Butterfly Portable Ultrasound Device With Bladder Ultrasound Images is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Healthcare provider performed PVR measurement using Butterfly and bladder ultrasound images

Device

The Urologic healthcare provider will perform PVR measurement on the participant (3 consecutive measurements during the same encounter) using the Butterfly and bladder ultrasound images

Self PVR measurement using Butterfly and bladder ultrasound images

Device

The participant will perform self PVR measurement (3 consecutive measurements during the same encounter) using the Butterfly and bladder ultrasound images (prior to catheterization, if needed)

Self PVR measurement using Butterfly and abstract bladder images

Device

The participant will perform self PVR measurement (3 consecutive measurements during the same encounter) using the Butterfly and abstract bladder images (prior to catheterization, if needed)

Healthcare provider performed PVR measurement using Butterfly and abstract bladder images

Device

The Urologic healthcare provider will perform PVR measurement on the participant (3 consecutive measurements during the same encounter) using the Butterfly and abstract bladder images

Healthcare provider performed standard PVR measurement using existing ultrasound technologyThe Urologic healthcare provider will perform standard point-of-care PVR measurement on the participant (3 consecutive measurements during the same encounter) using existing ultrasound technology

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: up to 6 months

This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months for reporting.