NCT04170413

Brief Summary

The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

November 14, 2019

Last Update Submit

November 2, 2020

Conditions

Neurogenic Bladder

Keywords

contrast ultrasoundurodynamics

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with successful completion of urodynamics

    All usual information gathered during urodynamics was able to be obtained

    After enrollment of 30 patients, estimated 1 year

Study Arms (1)

CeVUS Urodynamic

patients undergoing urodynamic study with CeVUS

Drug: CeVUS

Interventions

CeVUSDRUG

Contrast enhanced voiding urosonography

CeVUS Urodynamic

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics study

You may qualify if:

  • Age 0-18
  • Must have had prior urodynamic study at University of Virginia

You may not qualify if:

  • Pregnant women
  • Fetuses
  • Neonates
  • Prisoners
  • Subjects with preexisting cardiac conditions (such as heart failure and ventricular arrhythmias)
  • Subjects with a known hypersensitivity to Lumason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908-0170, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Reza Daugherty, MD

    University of Virginia Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology and Pediatrics

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 20, 2019

Study Start

January 1, 2020

Primary Completion

November 2, 2020

Study Completion

November 2, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

US(1)