Healthy VolunteersNCT00931593
Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry
A study testing Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization) in people with Healthy Volunteers, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal. The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- May 2009to Dec 2009
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female between 18 and 60 years
- Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)
- Subject without any medication (except oral contraception)
- Subject without previous digestive surgery history (except appendicectomy)
- Capability to pass manometric probes through each nostril
- Subject with health insurance
- Written informed consent
- No participation to another study at the same time
Who cannot join
- Age under 18 years or upper 60
- Pregnant woman or lactation
- Incapability to give consent
- No written informed consent
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Hôpital St André, CHU BORDEAUX
Bordeaux, 33075
ZERBIB Frank, MD, 05 56 79 58 06, frank.zerbib@chu-bordeaux.fr
ZERBIB Frank, MD
- Recruiting
Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69437
ROMAN Sabine, 04 72 11 01 36, sabine.roman@chu-lyon.fr
ROMAN Sabine, MD
- Not yet recruiting
Hôpital Hôtel Dieu, CHU NANTES
Nantes, 44093
BRULEY DES VARANNES Stanislas, MD, 02 40 08 31 65
BRULEY DE VARANNES Stanislas, MD
About this study
Official title: Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.
Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal.
The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.
Esophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.
- Conditions
- Healthy Volunteers
- Being tested
- Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)
- Keywords
- Transient lower esophageal sphincter relaxation, high resolution manometry, dentsleeve probe, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)Device
Visit V0 (day 0 - 2 to 14 days):
- Subject selection
- Obtaining of written informed consent
Visit V1 (day 0):
- Fasting subject
- Randomization to determine the examination order
- Esophageal high resolution manometry (Sierra Scientific Instruments, California CA) associated or not with manometry with perfused Dentsleeve probe (as determined by randomisation): 3-hour recording (1 hour fasting, ingestion of a 600-kcal liquid meal in 10 minutes, 2 hours post prandial)
Visit V2 (day 0 + 1 day): Phone contact
Visit V3 (day 0 + 2 to 7 days):
- Same as V1
Visit V4 (V3 + 1 day): Phone contact and end of the study
| Study group | Role | What they receive |
|---|---|---|
| volunteers | Experimental | This is a descriptive study to compare two techniques (manometry with perfused dentsleeve probe vs high resolution manometry for the identification of tLESr). Each subject is his own control.
The date of perfused manometry is randomized to avoid bias due to examinations' order. Receives: Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment.
Secondary outcomes (2)
To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe.
To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- ROMAN Sabine, MD, Principal investigator, Hospices Civils de LyonMION François, MD, Principal investigator, Hospices Civils de LyonBRULEY DES VARANNES Stanislas, MD, Principal investigator, CHRU NANTESZERBIB Frank, MD, Principal investigator, CHRU BORDEAUX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931593
- Sponsor's protocol ID
- 2008.546/47
- Status last verified
- Jul 2009
- First submitted
- 1 Jul 2009
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00931593
- Acronym / sponsor ID
- 2008.546/47
- Conditions
- Healthy Volunteers
- Keywords
- Transient lower esophageal sphincter relaxation, high resolution manometry, dentsleeve probe, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 2 Jul 2009 (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.
Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal.
The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.
Esophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | Experimental | Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)This is a descriptive study to compare two techniques (manometry with perfused dentsleeve probe vs high resolution manometry for the identification of tLESr). Each subject is his own control. The date of perfused manometry is randomized to avoid bias due to examinations' order. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or Female between 18 and 60 years
- Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)
- Subject without any medication (except oral contraception)
- Subject without previous digestive surgery history (except appendicectomy)
- Capability to pass manometric probes through each nostril
Key exclusion criteria (4 listed)
- Age under 18 years or upper 60
- Pregnant woman or lactation
- Incapability to give consent
- No written 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)Visit V0 (day 0 - 2 to 14 days): * Subject selection * Obtaining of written informed consent Visit V1 (day 0): * Fasting subject * Randomization to determine the examination order * Esophageal high resolution manometry (Sierra Scientific Instruments, California CA) associated or not with manometry with perfused Dentsleeve probe (as determined by randomisation): 3-hour recording (1 hour fasting, ingestion of a 600-kcal liquid meal in 10 minutes, 2 hours post prandial) Visit V2 (day 0 + 1 day): Phone contact Visit V3 (day 0 + 2 to 7 days): * Same as V1 Visit V4 (V3 + 1 day): Phone contact and end of the study | Device | volunteers |
Primary outcome
The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment.
2 secondary outcomes
To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe.
To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
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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.
ROMAN Sabine, MD principal investigator
Hospices Civils de Lyon
MION François, MD principal investigator
Hospices Civils de Lyon
BRULEY DES VARANNES Stanislas, MD principal investigator
CHRU NANTES
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization) in people with Healthy Volunteers, run by Hospices Civils de Lyon 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 4 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 2 Jul 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ROMAN Sabine, MD (04 72 11 01 36, sabine.roman@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment.. 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 2009.