RecruitingNCT07506746PREMUpdated Apr 2, 2026

PRospective Registry of Esophageal Motility

An observational study in Esophageal Diseases, Achalasia and Eosinophilic Esophagitis, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

Started Mar 2026; still recruiting 6 months later.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 10,000
Ages: 18 Years and older
Sex: All

Study 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).

Read the detailed description

Primary objective of the study is to create a prospective/retrospective registry of all patients with > 18 years of age referring to the Digestive Physiopathology division of San Raffaele Hospital, in order to register clinical, endoscopic, radiologic data of these patients integrating them with physiopatology outcomes in order to shape disease management and treatment work-up, also in long-term follow-up of these patients.

Primary endpoints are the Integration and analysis of association/correlation of physiologic with endoscopic, radiologic and clinical data.

PREM is a prospective registry recruiting patients retrospectively enrolled aiming[RT1.1] to include all clinical, endoscopic, radiological integrating them with physiopathology data of all patients referred to Digestive Physiopathology Division of San Raffaele Hospital, with the purpose of extracting data for prospective and retrospective analyses, in order to improve patients' management and clinical research and empower diagnostic and therapeutic work-up

Conditions studied

Esophageal Diseases
Achalasia
Eosinophilic Esophagitis
Motility Disorder
GERD

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Keywords

Esophageal disease; manometry; FLIP, pH-impedance

In context

Esophageal Diseases

79 studies on the registry are indexed under Esophageal Diseases; 21 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 500 across 25 observational studies indexed under Esophageal Diseases.

Browse Esophageal Diseases studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Patients with reflux (typical or atypical) or obstructive esophageal symptoms on or off therapy, Barrett Esophagus patients, pts with eosinophilic esophagitis, gastroparesis, patients with primary motility esophageal disorders, patients undergone to foregut GI surgery procedures (esophageal myotomies, anti-reflux surgeries, bariatric procedures, gastroparesis surgery), Age > 18 years

Inclusion criteria

Participant is willing and able to give informed consent for participation in the study.
The procedures are the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
Aged > 18 years.
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.
Patients must be referred to the Digestive Physiopathology Unit of IRCCS San Raffaele Hospital for motility tests

Exclusion criteria

Exclusion Criteria:

Age \< 18 years
Not willing to provide informed consent to the inclusion in the registry

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 10,000 participants (estimated)
Target follow-up: 10 Years
Patient registry: Yes

Interventions

OtherNo intervention
No intervention

What researchers measure

Primary outcomes

To collect High Resolution Manometry (HRM) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
To collect High Resolution Manometry (HRM) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
Time frame: 2026-2031
To collect pH-impedance data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
To collect pH-impedance data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
Time frame: 2026-2031

Secondary outcomes

To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: \- GERD-Q
Time frame: 2026-2031
To collect esophago-gastro-duodenoscopy (EGD) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
To collect esophago-gastro-duodenoscopy (EGD) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
Time frame: 2026-2031
To collect radiological (TBE, barium esophagogram) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
To collect radiological (TBE, barium esophagogram) data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
Time frame: 2026-2031
To collect anamnestic, clinical data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
To collect anamnestic, clinical data from patients referred for esophageal motility/inflammatory disorders or reflux/obstructive esophageal symptoms at Motility Unit of IRCCS San Raffaele Hospital
Time frame: 2026-2031
To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: -GERD-HRQL
Time frame: 2026-2031
To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: \- RSI
Time frame: 2026-2031
To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: \- BEDQ
Time frame: 2026-2031
To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: \- Eckardt score
Time frame: 2026-2031
To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: \- DSQ
Time frame: 2026-2031
To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: \- DD
Time frame: 2026-2031
To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: \- EoE-QoL-A
Time frame: 2026-2031
To collect clinical scores of activity with validated questionnaires from patients undergoing HRM+pH-impedance tests at Motility Unit of IRCCS San Raffaele Hospital
Questionnaires of clinical activity will be collected using validated questionnaires: \- PiEAQ score
Time frame: 2026-2031

Study locations

1 of 1 sites recruiting

IRCCS San Raffaele Hospital
Milan, Lombardy 20132, Italy
- Alberto Barchi, MD · Contact · barchi.alberto@hsr.it · +390226432643
Recruiting

References and documents

Publications

Carlson DA, Kahrilas PJ, Lin Z, Hirano I, Gonsalves N, Listernick Z, Ritter K, Tye M, Ponds FA, Wong I, Pandolfino JE. Evaluation of Esophageal Motility Utilizing the Functional Lumen Imaging Probe. Am J Gastroenterol. 2016 Dec;111(12):1726-1735. doi: 10.1038/ajg.2016.454. Epub 2016 Oct 11. PubMed 27725650 ↗
Salvador R, Pandolfino JE, Costantini M, Gyawali CP, Keller J, Mittal S, Roman S, Savarino EV, Tatum R, Tolone S, Zerbib F, Capovilla G, Jain A, Kathpalia P, Provenzano L, Yadlapati R; HRM & Foregut Surgery International Working Group. The Role of High-Resolution Manometry Before and Following Antireflux Surgery: The Padova Consensus. Ann Surg. 2025 Jan 1;281(1):124-135. doi: 10.1097/SLA.0000000000006297. Epub 2024 Apr 12. PubMed 38606560 ↗
Yadlapati R, Kahrilas PJ, Fox MR, Bredenoord AJ, Prakash Gyawali C, Roman S, Babaei A, Mittal RK, Rommel N, Savarino E, Sifrim D, Smout A, Vaezi MF, Zerbib F, Akiyama J, Bhatia S, Bor S, Carlson DA, Chen JW, Cisternas D, Cock C, Coss-Adame E, de Bortoli N, Defilippi C, Fass R, Ghoshal UC, Gonlachanvit S, Hani A, Hebbard GS, Wook Jung K, Katz P, Katzka DA, Khan A, Kohn GP, Lazarescu A, Lengliner J, Mittal SK, Omari T, Park MI, Penagini R, Pohl D, Richter JE, Serra J, Sweis R, Tack J, Tatum RP, Tutuian R, Vela MF, Wong RK, Wu JC, Xiao Y, Pandolfino JE. Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0(c). Neurogastroenterol Motil. 2021 Jan;33(1):e14058. doi: 10.1111/nmo.14058. PubMed 33373111 ↗

Study documents

Protocol and statistical analysis plan · Feb 2, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07506746
Lead sponsor: IRCCS San Raffaele
Responsible party: Alberto Barchi (Medical Doctor, IRCCS San Raffaele) — Principal investigator
First posted: Apr 2, 2026
Start date: Mar 9, 2026
Primary completion: Mar 2031 (estimated)
Completion: Mar 2041 (estimated)
Last update: Apr 2, 2026

Study contacts

Alberto Barchi, MD

Contact

barchi.alberto@hsr.it

+390226432643

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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