Gastroesophageal Reflux DiseaseHRM RTSIONCT01844440
Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD
A study testing High resolution manometry in people with Gastroesophageal Reflux Disease, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- High resolution manometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2013to Jan 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 75 years old
- GERD documented by :
- Typical reflux symptoms (heartburn, regurgitations) completely responsive to PPI therapy
- And/or erosive esophagitis or Barrett's esophagus at endoscopy
- And/or positive pH 24h monitoring (acid exposure time > 5% or positive symptom association indices)
- Possibility of easily positioned transnasal catheter
- Patients covered by social security
- Subjects must provide written, free and informed consent
Who cannot join
- Pregnant or lactating women
- History of digestive or thoracic surgery (except appendicectomy)
- Patients unable to stop PPI therapy for 7 days
- Subjects unable to provide written consent, including adult under guardianship and emergency situation
- Simultaneous participation in another study
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service d'hépato-gastroentérologie et oncologie digestive
Bordeaux, Bordeaux, 33075
Service d'Exploration Fonctionnelle Digestive
Lyon, Lyon, 69437
Institut des Maladies de l'Appareil Digestif (IMAD)
Nantes, Nantes, 44000
About this study
Official title: Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.
The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients.
Read the detailed description
tLESRs represent the main mechanism of all types of reflux events. Inhibition of transient lower esophageal sphincter relaxations (tLESRs) has become one of the most relevant therapeutic objectives in patients with reflux symptoms resistant to proton pump inhibitors. HRM is the gold standard for detecting and characterizing tLESR, and could be considered as part of the pharmacological evaluation of new drugs targeting tLESRs. HRM criteria for the objective definition of tLESRs in GERD patients have to be established, as it has been done in healthy patients Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- High resolution manometry
- Keywords
- GERD, tLESR, impedance, manometry
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution manometryProcedure or surgery
Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
| Study group | Role | What they receive |
|---|---|---|
| HRM | Experimental | Not described Receives: Procedure: High resolution manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
tLESRs characteristics
To characterize tLESRs defined according following criteria:
- LES basal pressure (mmHg) defined as LES pressure during relaxation
- LES minimum pressure during relaxation
- Duration of the LES relaxation (seconds)
- Integrated relaxation pressure (4 seconds)
Measured: Inclusion (Day 0)
Reflux underlying mechanisms
To detect every reflux and to determine underlying mechanisms
- Transient lower esophageal sphincter relaxations (tLESR)
- Low basal LES pressure (free reflux)
- Increased abdominal pressure
- Swallow
- Another mechanism
Measured: Inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank ZERBIB, MD-PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844440
- Sponsor's protocol ID
- CHUBX 2012/25
- Acronym
- HRM RTSIO
- Status last verified
- Jul 2014
- First submitted
- 1 Mar 2013
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.
- ClinicalTrials.gov ID
- NCT01844440
- Acronym / sponsor ID
- HRM RTSIO / CHUBX 2012/25
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, tLESR, impedance, manometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 May 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.
The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients.
Detailed description
tLESRs represent the main mechanism of all types of reflux events. Inhibition of transient lower esophageal sphincter relaxations (tLESRs) has become one of the most relevant therapeutic objectives in patients with reflux symptoms resistant to proton pump inhibitors. HRM is the gold standard for detecting and characterizing tLESR, and could be considered as part of the pharmacological evaluation of new drugs targeting tLESRs. HRM criteria for the objective definition of tLESRs in GERD patients have to be established, as it has been done in healthy patients Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRM | Experimental | Procedure: High resolution manometry |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients 18 to 75 years old
- GERD documented by :
- Possibility of easily positioned transnasal catheter
- Patients covered by social security
- Subjects must provide written, free and informed consent
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- History of digestive or thoracic surgery (except appendicectomy)
- Patients unable to stop PPI therapy for 7 days
- Subjects unable to provide written consent, including adult under guardianship and emergency situation
- Simultaneous participation in another study
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 |
|---|---|---|
| High resolution manometrySubjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods. | Procedure or surgery | HRM |
Primary outcome
tLESRs characteristics
Time frame: Inclusion (Day 0)
To characterize tLESRs defined according following criteria: * LES basal pressure (mmHg) defined as LES pressure during relaxation * LES minimum pressure during relaxation * Duration of the LES relaxation (seconds) * Integrated relaxation pressure (4 seconds)
Reflux underlying mechanisms
Time frame: Inclusion (Day 0)
To detect every reflux and to determine underlying mechanisms * Transient lower esophageal sphincter relaxations (tLESR) * Low basal LES pressure (free reflux) * Increased abdominal pressure * Swallow * Another mechanism
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 2 Jul 2014.
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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.
Frank ZERBIB, MD-PhD principal investigator
University Hospital, Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution manometry in people with Gastroesophageal Reflux Disease, run by University Hospital, Bordeaux at 3 sites in France.
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 8 inclusion and 5 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 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
tLESRs characteristics (time frame: Inclusion (Day 0)). The study lists 2 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 2 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.