Reproducibility of Flow Measurements in the SMA Using Doppler Ultrasound

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: Completed
• Conditions: Ultrasound
• Intervention / Treatment: Other: Doppler Ultrasound

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: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Intra-period reproducibility of flow measurements	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	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	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	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	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

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Actual): July 4, 2019
• Study Completion (Actual): July 4, 2019

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID 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