Reproducibility of Flow Measurements in the SMA Using Doppler Ultrasound

June 2, 2020 updated by: Universitaire Ziekenhuizen KU Leuven

Evaluating Reproducibility of Flow Measurements in the Superior Mesenteric Artery in Healthy Male Subjects Using Doppler Ultrasound

This will be a single center, methodological study in healthy male subjects to evaluate the intra-period, inter-period and inter-observer reproducibility of flow measurements in the superior mesenteric artery, using Doppler Ultrasound.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a single center, methodological study in healthy male subjects, aged 18-50, to evaluate the intra-period, inter-period and inter-observer reproducibility of flow measurements in the superior mesenteric artery, using Doppler Ultrasound.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

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

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Center for Clinical Pharmacology

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Healthy male volunteers

Description

Inclusion Criteria:

  • Subject is a male ≥18 and ≤ 50 years of age.
  • Subject is a non-smoker for at least 6 months prior to study start.
  • Subject has a body mass index between 18-28 kg/m2.
  • Subject is judged to be in good health on the basis of medical history and vital signs.
  • Subject understands the procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria:

  • Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study.
  • Subject has burns, scars, flaps or grafts on the abdomen which, in the investigator's opinion, may interfere with the study assessments.
  • Subject has an anatomical anomaly of the SMA as evaluated with DUS during screening which, in the investigator's opinion, may interfere with the study assessments.
  • Subject currently uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study. Subject has taken 7 days prior to the start of the study any prescription or non-prescription drugs which, in the investigator's opinion, might confound the results of the study.
  • Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit or has a history of drug (including alcohol) abuse.
  • Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, …) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study.
  • Subject has any of the following vital sign measurements at screening: Heart Rate <40 or >100 beats/min, Diastolic Blood Pressure <50 or >90 mmHg, Systolic Blood Pressure <90 or >140 mmHg.
  • Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks.
  • Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observational
Doppler Ultrasound will be performed in all subjects.
Other: Doppler Ultrasound
Flow measurements using Doppler ultrasound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intra-period reproducibility of flow measurements
Time Frame: Interval of 30 minutes between two measurements during study visit 1
Reproducibility of flow measurements performed during study visit 1 by the same observer.
Interval of 30 minutes between two measurements during study visit 1
Intra-period reproducibility of flow measurements
Time Frame: Interval of 30 minutes between two measurements during study visit 2
Reproducibility of flow measurements performed during study visit 2 by the same observer.
Interval of 30 minutes between two measurements during study visit 2
Inter-period reproducibility of flow measurements
Time Frame: Interval of at least 3 days between both study visits
Reproducibility (i.e. assessing changes) of flow measurements performed during two separate study visits by the same observer
Interval of at least 3 days between both study visits
Inter-observer reproducibility of flow measurements
Time Frame: Interval of 15 minutes between two measurements during study visit1
Reproducibility of flow measurements performed during study visit 1 by two different observers.
Interval of 15 minutes between two measurements during study visit1
Inter-observer reproducibility of flow measurements
Time Frame: Interval of 15 minutes between two measurements during study visit 2
Reproducibility of flow measurements performed during study visit 2 by two different observers.
Interval of 15 minutes between two measurements during study visit 2

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCP19-3306-DUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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