UltrasoundNCT04419220
Reproducibility of Flow Measurements in the SMA Using Doppler Ultrasound
An observational study of Ultrasound, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasound
- What is being tested?
- Doppler Ultrasound
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 27 May 2019to 4 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy male volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Doppler Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler UltrasoundOther
Flow measurements using Doppler ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Observational | Doppler Ultrasound will be performed in all subjects. Receives: Other: Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-period reproducibility of flow measurements
Reproducibility of flow measurements performed during study visit 1 by the same observer.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Interval of 15 minutes between two measurements during study visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start27 May 2019
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419220
- Sponsor's protocol ID
- CCP19-3306-DUS
- Status last verified
- Jun 2020
- First submitted
- 6 May 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Reproducibility of Flow Measurements in the Superior Mesenteric Artery in Healthy Male Subjects Using Doppler Ultrasound
- ClinicalTrials.gov ID
- NCT04419220
- Acronym / sponsor ID
- CCP19-3306-DUS
- Conditions
- Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Doppler UltrasoundDoppler Ultrasound will be performed in all subjects. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male volunteers
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler UltrasoundFlow measurements using Doppler ultrasound | Other | Observational |
Primary outcome
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.
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-period reproducibility of flow measurements (time frame: Interval of 30 minutes between two measurements during study visit 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.