NCT07506746 PRospective Registry of Esophageal Motility
| NCT ID | NCT07506746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Esophageal Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2031-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2026-03-09 with a primary completion date of 2031-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Digestive physiopathology is a branch of gastroenterology aiming to study patients with upper GI symptoms, mainly gastro-esophageal, potentially indicating the presence of Gastroesophageal Reflux Disease (GERD)/Barrett Esophagus (BE) or obstructive esophageal motility disorders (achalasia being the most relevant), but including also other primary motility disorders such as Esophgago-Gastric Junction Outflow Obstruction (EGJOO), Hypercontractile Esophagus (HE), Distal Esophageal Spasm (DES) and other minor disorders. Physiopathological testing encompasses High-Resolution Manometry (HRM), 24-H esophageal pH-impedance testing, Functional Lumen Imaging Probe (FLIP) assessment. All these tests are designed to provide a clear phenotyping of esophago-gastric disorders related to reflux or obstructive esophageal symptoms, either in naïve patients, as well as after foregut surgery (particularly anti-reflux surgery, achalasia/primary motility disorders treatment).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07506746 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07506746 currently recruiting?
Yes, NCT07506746 is actively recruiting participants. Contact the research team at barchi.alberto@hsr.it for enrollment information.
Where is the NCT07506746 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07506746 clinical trial?
NCT07506746 is sponsored by IRCCS San Raffaele. The trial plans to enroll 10,000 participants.