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New treatment option for Gastro-esophageal Reflux Disease
Official title Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
ClinicalTrials.gov ID: NCT03596476
What this study is testing
- What it's testing
- Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient older than 18 years
- Typical symptoms of GERD (heartburn, regurgitation) at least twice a week despite PPI therapy for at least one month.
- Reflux Disease Questionnaire (RDQ) score off PPI \> 3
- Subject with health insurance
You likely can't join if
- Previous esophago-gastric surgery,
- Previous history of developing esophageal or gastric tumor, esophageal stricture, or esophageal varices
- Pregnancy (assessment at V0)
- Contraindication to general anesthesia,
- Contraindications to the wireless capsule pH-monitoring: pacemakers, implantable cardiac defibrillator,
- Contraindications to HRIM: inability to tolerate nasal intubation, significant bleeding disorders for which nasal intubation is contraindicated...
See the full eligibility criteria
- Patient older than 18 years
- Typical symptoms of GERD (heartburn, regurgitation) at least twice a week despite PPI therapy for at least one month.
- Reflux Disease Questionnaire (RDQ) score off PPI \> 3
- Subject with health insurance
- Previous esophago-gastric surgery,
- Previous history of developing esophageal or gastric tumor, esophageal stricture, or esophageal varices
- Pregnancy (assessment at V0)
- Contraindication to general anesthesia,
- Contraindications to the wireless capsule pH-monitoring: pacemakers, implantable cardiac defibrillator,
- Contraindications to HRIM: inability to tolerate nasal intubation, significant bleeding disorders for which nasal intubation is contraindicated, known esophageal obstruction is preventing the passage of the HRIM probe.
- Intolerance or allergy to one component of the test meal,
- Intolerance or allergy to PPI,
- Inability to give consent,
- Mentally unbalanced patients, under supervision or guardianship
- Decline to participate in the study,
- Participation in another study at the same time
The study team makes the final eligibility decision.
Where it's taking place
- Chambray-lès-Tours, France
- Colombes, France
- Lyon, France
- Nantes, France
- Pessac, France
- Rennes, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chambray-lès-Tours, France; Colombes, France; Lyon, France; Nantes, France; Pessac, France; Rennes, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.