Reproducibility of Flow Measurements in the SMA Using Doppler Ultrasound

NCT04419220 | Completed

• 1 other identifier: CCP19-3306-DUS
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasound

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Observational

Doppler Ultrasound will be performed in all subjects.

Other: Doppler Ultrasound

Interventions

Doppler Ultrasound OTHER

Flow measurements using Doppler ultrasound

Observational

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Center for Clinical Pharmacology

Leuven, Vlaams Brabant, 3000, Belgium

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: June 5, 2020
• Study Start: May 27, 2019
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

BE (1)