Multi-organ Transit Time Acquisition Using Contrast Ultrasound

September 19, 2023 updated by: Ken Monahan, Vanderbilt University Medical Center
Echocardiographic contrast will be administered to volunteers for the purpose of measuring transit time through various organs/vascular beds

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • VUmc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Cross-section of VHVI faculty and sonographers

Description

Inclusion Criteria:

  • at least 18 years old
  • able to give informed consent

Exclusion Criteria:

  1. Known allergic reaction to Definity ultrasound contrast
  2. Pregnancy/Nursing - as assessed/disclosed by the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Contrast administration
Drug: Definity Suspension for Injection
Administration of Definity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
transit time
Time Frame: during procedure
time it takes for contrast to traverse an organ
during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Actual)

June 16, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB 212087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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