Evaluation of Esophageal Motility Utilizing the Functional Lumen Imaging Probe.
Dustin A Carlson, Peter J Kahrilas, Zhiyue Lin...
https://pubmed.ncbi.nlm.nih.gov/27725650Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID07506746
PRospective Registry of Esophageal Motility for Patients with Esophageal Motility and Reflux Disorders
Led by IRCCS San Raffaele · Updated on 2026-04-02
10000
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with upper digestive tract symptoms, especially those that may indicate conditions like Gastroesophageal Reflux Disease (GERD), Barrett Esophagus, or various esophageal motility disorders such as achalasia and others. This observational study aims to create a detailed registry to better understand these digestive conditions by collecting clinical, endoscopic, radiologic, and physiological data. The research will help improve diagnosis and management of esophageal disorders by integrating information from multiple sources over time. The study collects data using specialized tests including High-Resolution Manometry, 24-hour esophageal pH-impedance monitoring, and Functional Lumen Imaging Probe assessments. These tests help profile esophageal motility and reflux issues in patients either new to treatment or after surgeries like anti-reflux procedures. Participants will be those referred to the Digestive Physiopathology Unit, and the registry gathers both retrospective and prospective data to support ongoing research. Participants will undergo standard care procedures including clinical evaluations, endoscopy, radiologic imaging, and validated questionnaires to assess symptom activity. Data collection spans several years, from 2026 to 2031, with the aim to track and analyze physiological, clinical, and imaging results. The study will monitor safety and disease progression while helping to shape future treatment approaches through long-term follow-up.
CONDITIONS
Brief Title
PRospective Registry of Esophageal Motility
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Participant is willing and able to give informed consent for participation in the study.
- Procedures performed are part of standard care or participant is taking medication as per clinical practice.
- Aged over 18 years.
- Presence of typical or atypical reflux symptoms, obstructive esophageal symptoms, or diagnosis of esophageal inflammatory or systemic rheumatological conditions.
- Patients previously undergone anti-reflux surgery, bariatric surgery, or esophageal/gastric myotomy may be included.
- Patients must be referred to the Digestive Physiopathology Unit of IRCCS San Raffaele Hospital for motility tests.
You will not qualify if you...
- Age under 18 years.
- Not willing to provide informed consent for inclusion in the registry.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Ongoing as part of standard care
Participants undergo physiopathological testing including High-Resolution Manometry (HRM), 24-H esophageal pH-impedance testing, and Functional Lumen Imaging Probe (FLIP) assessment to provide clear phenotyping of esophago-gastric disorders related to reflux or obstructive esophageal symptoms.
Visits as per standard clinical practice
Long-term Monitoring
Duration - Up to 5 years
Participants are followed over time to collect clinical, endoscopic, radiologic, and physiopathology data to improve disease management and treatment work-up.
Follow-up visits depending on clinical needs
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Hospital
Milan, Lombardy, Italy, 20132
Actively Recruiting
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Research Team
A
Alberto Barchi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
The Role of High-Resolution Manometry Before and Following Antireflux Surgery: The Padova Consensus.
Renato Salvador, John E Pandolfino, Mario Costantini...
https://pubmed.ncbi.nlm.nih.gov/38606560Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0©.
Rena Yadlapati, Peter J Kahrilas, Mark R Fox...
https://pubmed.ncbi.nlm.nih.gov/33373111