Clinical trialNCT01956877
Assessment of Normal Values of Esophagogastric Junction (EGJ) Distensibility in Healthy Volunteers
An observational study, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
To assess normal values of EGJ distensibility in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to Aug 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 15 healthy volunteers, age > years
Who may be able to join
- No history of gastrointestinal disease, especially gastro-esophageal reflux disease
- BMI = 18-30 kg/m²
- Caucasian race
- Subject signed the informed consent form and is able to adhere to study protocol
Who cannot join
- Age < 18 years
- Previous esophageal or gastric surgery
- Co-morbidities (including cardiopulmonary disease, collagen diseases, obesity, coagulation disorders and co-morbidity hindering upper gastrointestinal endoscopy)
- Patients using anticoagulants
- Patients unable to give informed consent
- Smoking
- History of alcohol abuse or current excessive alcohol consumption (> 2 alcoholic beverages per day or > 14 alcoholic beverages per week)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, 6229 HX
Fabienne Smeets, MD, +3143-3875021, FGM.Smeets@student.maastrichtuniversity.nl
José M Conchillo, MD PhD
About this study
To assess normal values of EGJ distensibility in healthy volunteers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
normal values of esophagogastric junction (EGJ) distensibility (mm2/mmHg) in healthy volunteers as measured with the EndoFLIP device
EGJ distensibility as measured by the index of the narrowest cross sectional area (mm2) and the corresponding intrabag pressure (mmHg)
Measured: 3 months
Secondary outcomes (1)
Establishing a cut-off value of EGJ distensibility (mm2/mmHg) based on the 90% percentile distribution of measurements performed in healthy volunteers.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- More trials run by Maastricht University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956877
- Sponsor's protocol ID
- NL45176.068.13
- Status last verified
- Aug 2014
- First submitted
- 16 Sep 2013
- Last updated
- 5 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Normal Values of Esophagogastric Junction (EGJ) Distensibility in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01956877
- Acronym / sponsor ID
- NL45176.068.13
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- 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.
To assess normal values of EGJ distensibility in healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 15 healthy volunteers, age > years
Key inclusion criteria (4 listed)
- No history of gastrointestinal disease, especially gastro-esophageal reflux disease
- BMI = 18-30 kg/m²
- Caucasian race
- Subject signed the informed consent form and is able to adhere to study protocol
Key exclusion criteria (7 listed)
- Age < 18 years
- Previous esophageal or gastric surgery
- Co-morbidities (including cardiopulmonary disease, collagen diseases, obesity, coagulation disorders and co-morbidity hindering upper gastrointestinal endoscopy)
- Patients using anticoagulants
- Patients unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
normal values of esophagogastric junction (EGJ) distensibility (mm2/mmHg) in healthy volunteers as measured with the EndoFLIP device
Time frame: 3 months
EGJ distensibility as measured by the index of the narrowest cross sectional area (mm2) and the corresponding intrabag pressure (mmHg)
1 secondary outcome
Establishing a cut-off value of EGJ distensibility (mm2/mmHg) based on the 90% percentile distribution of measurements performed in healthy volunteers.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Aug 2014. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabienne Smeets, MD (+31433875021, FGM.Smeets@student.maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normal values of esophagogastric junction (EGJ) distensibility (mm2/mmHg) in healthy volunteers as measured with the EndoFLIP device (time frame: 3 months). 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 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.