Esophageal DiseasesPREMNCT07506746
PRospective Registry of Esophageal Motility
An observational study of Esophageal Diseases and Achalasia, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Diseases, Achalasia, Eosinophilic Esophagitis
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2026to Mar 2041
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Not willing to provide informed consent to the inclusion in the registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Hospital
Milan, Lombardy, 20132
Alberto Barchi, MD, +390226432643, barchi.alberto@hsr.it
About this study
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
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).
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
- Being tested
- No intervention
- Keywords
- Esophageal disease; manometry; FLIP, pH-impedance
- Medical subject headings
- Esophageal Diseases, Esophageal Achalasia, Eosinophilic Esophagitis, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2026-2031
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2026-2031
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start9 Mar 2026
- Primary completionMar 2031 (estimated)
- Study completionMar 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Barchi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506746
- Sponsor's protocol ID
- PREM
- Acronym
- PREM
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27725650Salvador 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 38606560Yadlapati 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 at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Registry of Esophageal Motility
- ClinicalTrials.gov ID
- NCT07506746
- Acronym / sponsor ID
- PREM / PREM
- Keywords
- Esophageal disease; manometry; FLIP, pH-impedance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2041 (estimated)
- First posted
- 2 Apr 2026 (actual)
- 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.
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).
Detailed description
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).
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18 years
- Not willing to provide informed consent to the inclusion in the registry
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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 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 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
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
12 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
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
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
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
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
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
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
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
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
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
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
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
Time frame: 2026-2031
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 27725650Carlson 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.
- Background: PubMed 38606560Salvador 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.
- Results publication: PubMed 33373111Yadlapati 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Diseases and Achalasia, run by IRCCS San Raffaele at 1 site in Italy.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Barchi, MD (+390226432643, barchi.alberto@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07506746, which also lists 3 linked publications.
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 2 Apr 2026.