Reproducibility of Flow Measurements in the SMA Using Doppler Ultrasound

NCT ID: NCT04419220

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2019-07-04

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.

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.

Conditions

Ultrasound

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational

Doppler Ultrasound will be performed in all subjects.

Doppler Ultrasound

Intervention Type: OTHER

Flow measurements using Doppler ultrasound

Interventions

Doppler Ultrasound

Flow measurements using Doppler ultrasound

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Clinical Pharmacology

Leuven, Vlaams Brabant, Belgium

Countries

Belgium

Other Identifiers

CCP19-3306-DUS

Identifier Type: -

Identifier Source: org_study_id