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

NCT05295823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-15

No results posted yet for this study

Summary

This study would be the first to demonstrate feasibility, accuracy, reliability, clinical care impact, and patient satisfaction with remote monitoring of post-void residual bladder volume (PVR) using the Butterfly portable ultrasound device in patients with obstructive voiding dysfunction.

Conditions

  • Voiding Disorders
  • Voiding Dysfunction

Interventions

DEVICE

Butterfly portable ultrasound device with bladder ultrasound images

Point-of-care PVR measurement using existing ultrasound technology (3 consecutive measurements during the same encounter) the Butterfly portable ultrasound device with bladder ultrasound images

DEVICE

Butterfly portable ultrasound device with abstract bladder images

Point-of-care PVR measurement using the Butterfly portable ultrasound device with abstract bladder images

Sponsors & Collaborators

  • Butterfly Network, Inc

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Jaime Cavallo, MD, MPHS · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2022-06-03
Completion
2022-06-03
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05295823 on ClinicalTrials.gov