Multi-organ Transit Time Acquisition Using Contrast Ultra... | NCT05135169

Studies
Multi-organ Transit Time Acquisition Using Contrast Ultrasound

NCT05135169

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Jul 9, 2025Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Healthy

Interventions

Definity Suspension for Injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2022Actual

Primary Completion Date

Jun 16, 2023Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Nov 2, 2021

First Submission Date that Met QC Criteria

Nov 23, 2021

First Posted Date

Nov 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2025

Last Update Posted Date

Jul 9, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ken Monahan, Assistant Professor, Vanderbilt University Medical CenterPrincipal Investigator

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Echocardiographic contrast will be administered to volunteers for the purpose of measuring transit time through various organs/vascular beds

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Contrast administration			Drug: Definity Suspension for Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Definity Suspension for Injection	Drug	Administration of Definity	Contrast administration

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 18 years old
able to give informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cross-section of VHVI faculty and sonographers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VUMC		Nashville	Tennessee	37232	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007267	Injections

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided