Esophageal DysfunctionNormaFLIPNCT02905669
Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP)
A study testing EndoFLIP in people with Esophageal Dysfunction and Pylorus Dysfunction, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Dysfunction, Pylorus Dysfunction
- What is being tested?
- EndoFLIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2017to 25 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject older than 18 years and younger than 80 years
- Subject referred for upper gastro-intestinal endoscopy under general anesthesia for anemia, intestinal metaplasia in the stomach, Helicobacter pylori screening, or submucosal dissection
- Subject with health insurance
- Written informed consent
Who cannot join
- Patient younger than 18 years or older than 80 years
- Pregnancy or breast feeding
- Previous history of esophago-gastric surgery or vagotomy
- Previous history of Parkinson disease or diabetes mellitus
- Contra-indication to upper gastro-intestinal endoscopy
- Esophageal varices
Show all 16Show fewer
- Esophageal diameter smaller than 5 mm
- Contra-indication to general anesthesia
- Hiatal hernia greater than 3 cm on endoscopy
- Esophageal or gastric cancer otherwise than superficial lesion with indication of submucosal dissection
- Typical symptoms (heartburn, regurgitation) of gastro-esophageal reflux disease and/or gastroesophageal reflux disease (GERD)-Q score greater or equal to 8
- Nausea, vomiting or epigastric pain
- Dysphagia with Sydney score greater ou equal to 50
- Incapability to give consent
- No written informed consent
- Participation to another study at the same time
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot
Lyon, 69437
Sabine ROMAN, MD, PhD, +33472110146, sabine.roman@chu-lyon.fr
Sabine ROMAN, MD, PhD
About this study
Official title: Measurement of Contractile Activity and Distensibility of the Esophago-gastric Junction, of the Esophagus and of the Pylorus: Normal Values in Controls Under General Anesthesia (NormaFLIP Study)
Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.
- Conditions
- Esophageal Dysfunction, Pylorus Dysfunction
- Being tested
- EndoFLIP
- Keywords
- distensibility, impedance planimetry, esophagus, esophago-gastric junction, pylorus
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoFLIPDevice
Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device
| Study group | Role | What they receive |
|---|---|---|
| EndoFLIP | Experimental | Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device. Receives: Device: EndoFLIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophago-gastric junction distensibility
Measured: The day of gastro-intestinal endoscopy
Secondary outcomes (5)
Esophageal distensibility
Measured: The day of gastro-intestinal endoscopy
Pylorus distensibility
Measured: The day of gastro-intestinal endoscopy
Esophageal contractile activity in response to distension
distension volume for presence of esophageal repetitive contraction
Measured: The day of gastro-intestinal endoscopy
Side effects occurence
Occurrence of pain, aspiration and vomiting
Measured: The day of gastro-intestinal endoscopy
Side effects occurence
Occurrence of pain, aspiration and vomiting
Measured: The day after gastro-intestinal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start13 Sep 2017
- Primary completion25 May 2024 (estimated)
- Study completion25 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DysfunctionStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905669
- Sponsor's protocol ID
- 69HCL16_0457
- Acronym
- NormaFLIP
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2016
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Contractile Activity and Distensibility of the Esophago-gastric Junction, of the Esophagus and of the Pylorus: Normal Values in Controls Under General Anesthesia (NormaFLIP Study)
- ClinicalTrials.gov ID
- NCT02905669
- Acronym / sponsor ID
- NormaFLIP / 69HCL16_0457
- Conditions
- Esophageal Dysfunction, Pylorus Dysfunction
- Keywords
- distensibility, impedance planimetry, esophagus, esophago-gastric junction, pylorus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 25 May 2024 (estimated)
- First posted
- 19 Sep 2016 (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.
Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoFLIP | Experimental | Device: EndoFLIPEsophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject older than 18 years and younger than 80 years
- Subject referred for upper gastro-intestinal endoscopy under general anesthesia for anemia, intestinal metaplasia in the stomach, Helicobacter pylori screening, or submucosal dissection
- Subject with health insurance
- Written informed consent
Key exclusion criteria (16 listed)
- Patient younger than 18 years or older than 80 years
- Pregnancy or breast feeding
- Previous history of esophago-gastric surgery or vagotomy
- Previous history of Parkinson disease or diabetes mellitus
- Contra-indication to upper gastro-intestinal endoscopy
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 |
|---|---|---|
| EndoFLIPEsophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device | Device | EndoFLIP |
Primary outcome
Esophago-gastric junction distensibility
Time frame: The day of gastro-intestinal endoscopy
5 secondary outcomes
Esophageal distensibility
Time frame: The day of gastro-intestinal endoscopy
Pylorus distensibility
Time frame: The day of gastro-intestinal endoscopy
Esophageal contractile activity in response to distension
Time frame: The day of gastro-intestinal endoscopy
Side effects occurence
Time frame: The day of gastro-intestinal endoscopy
Side effects occurence
Time frame: The day after gastro-intestinal endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoFLIP in people with Esophageal Dysfunction and Pylorus Dysfunction, run by Hospices Civils de Lyon at 1 site 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 4 inclusion and 16 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 21 Mar 2022. 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 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 Sabine ROMAN, MD, PhD (+33472110146, 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?
Esophago-gastric junction distensibility (time frame: The day of gastro-intestinal endoscopy). 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 21 Mar 2022.