A registry for adults with esophageal movement and reflux problems.
PRospective Registry of Esophageal Motility
This project will collect esophageal function tests (manometry, pH-impedance, FLIP) and clinical data from adults with reflux or swallowing symptoms to see if combining these results helps guide diagnosis and long-term care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT07506746 on ClinicalTrials.gov |
What this trial studies
This registry enrolls adults referred to the Digestive Physiopathology division at IRCCS San Raffaele and captures clinical, endoscopic, radiologic and surgical history. Participants undergo standard-of-care physiologic testing including high-resolution manometry, 24-hour pH-impedance monitoring and FLIP, whether they are treatment-naïve or post-foregut surgery. The dataset integrates multimodal physiologic measurements with clinical outcomes to identify phenotypes of GERD, achalasia and other motility disorders and to support long-term follow-up. Analyses will focus on correlations between physiologic findings and clinical/endoscopic/radiologic data to better inform diagnostic and management pathways.
Who should consider this trial
Good fit: Adults over 18 referred to the Digestive Physiopathology division for typical or atypical reflux symptoms or for obstructive esophageal symptoms, whether before or after foregut surgery, are ideal candidates.
Not a fit: People without esophageal or reflux-related symptoms, children under 18, or patients who do not undergo the listed standard-of-care tests or decline consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could help clinicians match specific physiologic patterns to optimal treatments and improve long-term outcomes for people with reflux and motility disorders.
How similar studies have performed: Individual studies using manometry, pH-impedance or FLIP have influenced clinical care, but prospective integrated registries combining these modalities are less common and their broad impact is still being established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. The procedures are the standard of care for the patient or the participant is taking the medicinal product according to clinical practice 3. Aged \> 18 years. 4. Any typical (heartburn or regurgitation) or atypical reflux symptom (Laryngeal Cough, laryngitis, sub-glottic stenosis, globus, laryngeal cancer, vocal cord granuloma, vocal cord irritation, vocal cord polyps and post-nasal drip; Oropharyngeal: Dental erosion, pharyngitis, sore or burning throat, gingivitis and halitosis; Ears and sinuses: Earaches, otitis media and sinusitis; Pulmonary: Chronic bronchitis, pneumonia, aspiration, bronchiectasis, asthma and idiopathic pulmonary fibrosis; Cardiac: Arrhythmia, angina and myocardial infarction; Sleep: Sleep apnoea, sleep deprivation, insomnia, snoring, nightmare and sleep disturbance), but also any obstructive esophageal symptom potentially reflecting a primary or secondary motility disorder (oropharyngeal or esophageal dysphagia, chest pain, bolus impaction). Every patient with a diagnosis of esophageal inflammatory disorder (including EoE and others) or systemic rheumatological condition (scleroderma, systemic sclerosis, lichen planus and others), every patient previously undergone to any anti-reflux surgery, bariatric surgery, endoscopic or surgical esophageal or gastric myotomy (also for gastroparesis) may be included. 5. Patients must be referred to the Digestive Physiopathology Unit of IRCCS San Raffaele Hospital for motility tests Exclusion Criteria: 1. Age \< 18 years 2. Not willing to provide informed consent to the inclusion in the registry
Where this trial is running
Milan, Lombardy
- IRCCS San Raffaele Hospital — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Alberto Barchi, MD
- Email: barchi.alberto@hsr.it
- Phone: +390226432643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.