Skip to main content
OpenTrials
Completed

NCT Number: NCT04419220

Reproducibility of Flow Measurements in the SMA 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ultrasound

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Center for Clinical Pharmacology

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doppler Ultrasound

Other

Flow measurements using Doppler ultrasound

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.