Oesophageal RefluxNCT05214079
Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance
A study testing Left paratracheal pressure in people with Oesophageal Reflux, run by University of Liege.
Trial summary
Determine the force required to occlude the esophagus with a left paratracheal pressure Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oesophageal Reflux
- What is being tested?
- Left paratracheal pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Sep 2022
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physical status score 1 or 2
- No contre indication to Left Paratracheal pressure
Who cannot join
- Obese patients
- Physical status score 3, 4 or 5
- Contre indication to Left Paratracheal pressure
Trial locations and contacts
No sites are listed yet.
About this study
Determine the force required to occlude the esophagus with a left paratracheal pressure
- Conditions
- Oesophageal Reflux
- Being tested
- Left paratracheal pressure
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left paratracheal pressureDevice
Applying Left Paratracheal pressure and testing its effectiveness using gastric tube . in addition , by using the dynamometer , the CP 50 is defined.
| Study group | Role | What they receive |
|---|---|---|
| 1 , Left paratracheal pressure | Active comparator | 50 male Receives: Device: Left paratracheal pressure |
| 2, Left paratracheal pressure | Active comparator | 50 female Receives: Device: Left paratracheal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necessary force of Left paratracheal pressure to occlude the esophagus in female versus male . an up and down method will define the CP 50 in each gender. A comparison between CP50 in both sex will define exactly our outcome
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Mar 2022 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal RefluxStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, MD, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214079
- Sponsor's protocol ID
- Strenght_LPP
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance
- ClinicalTrials.gov ID
- NCT05214079
- Acronym / sponsor ID
- Strenght_LPP
- Conditions
- Oesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 28 Jan 2022 (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.
Determine the force required to occlude the esophagus with a left paratracheal pressure
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 , Left paratracheal pressure | Active comparator | Device: Left paratracheal pressure50 male |
| 2, Left paratracheal pressure | Active comparator | Device: Left paratracheal pressure50 female |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physical status score 1 or 2
- No contre indication to Left Paratracheal pressure
Key exclusion criteria (3 listed)
- Obese patients
- Physical status score 3, 4 or 5
- Contre indication to Left Paratracheal pressure
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 |
|---|---|---|
| Left paratracheal pressureApplying Left Paratracheal pressure and testing its effectiveness using gastric tube . in addition , by using the dynamometer , the CP 50 is defined. | Device | 1 , Left paratracheal pressure, 2, Left paratracheal pressure |
Primary outcome
Necessary force of Left paratracheal pressure to occlude the esophagus in female versus male . an up and down method will define the CP 50 in each gender. A comparison between CP50 in both sex will define exactly our outcome
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Left paratracheal pressure in people with Oesophageal Reflux, run by University of Liege.
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 2 inclusion and 3 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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Benjamin Javillier, MD (43667180 ext. +32, javillier.benjamin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Necessary force of Left paratracheal pressure to occlude the esophagus in female versus male . an up and down method will define the CP 50 in each gender. A comparison between CP50 in both sex will define exactly our outcome (time frame: 24 hours). 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 28 Jan 2022.