Meta description: regulatory update on the European Transoral Incisionless Fundoplication 2.0 registry covering gastro oesophagal reflux and laryngo pharyngeal reflux, with invitation only enrollment and EsophyX device use.
As of February 19 2026 regulatory watchers should note a focused registry entry for patients with GERD and LPR who are treated with Transoral incisionless fundoplication using the EsophyX device with or without hiatal hernia repair. The sponsor listed is Cleveland Clinic London and enrollment is by invitation only. This is a data collection activity described on ClinicalTrials.gov under NCT07395219.
What changed in the European Transoral Incisionless Fundoplication 2.0 Registry?
The registry captures the conditions Gastro Oesophagal Reflux and Laryngo Pharyngeal Reflux and records the procedure Transoral incisionless fundoplication with or without hiatal hernia repair using the EsophyX device. Cleveland Clinic London is listed as sponsor and enrollment is described as enrolling by invitation. The record on ClinicalTrials.gov is NCT07395219 with the term medical device indicating the official reference for this listing.
Enrollment by invitation reflects a controlled approach to site and patient participation. Defined criteria and sponsor led selection support data integrity and patient safety oversight.
For reference the ClinicalTrials.gov entry is available with the exact study number NCT07395219. External link provided here for regulatory context.
Internal links to related regulatory coverage are provided for readers seeking broader MDR context: EU TIF 2.0 registry update and MDR post market surveillance in practice.
External authoritative reference: ClinicalTrials.gov NCT07395219.
What is the EsophyX device and how is it used in TIF 2.0?
Transoral incisionless fundoplication with the EsophyX device represents an endoscopic approach to reinforce the gastro esophageal junction. The option to perform hiatal hernia repair is described as part of the intervention in the registry listing, depending on patient anatomy and surgical planning.
Who is affected by this registry update?
Clinicians and site staff performing the procedure are likely to review registry elements in the European setting. Sponsors and regulatory teams will assess data collection and reporting obligations under European MDR rules. Quality teams should consider how enrollment by invitation affects governance and data quality controls.
What are the regulatory implications for devices and sponsors?
The registry aligns with post market data requirements under MDR Annex XIV and supports real world evidence generation for a device used for GERD and LPR indications. The listing of sponsor and device name aids traceability and accountability for data handling and safety reporting.
What does enrolling by invitation mean for investigators and sites?
Investigators and sites are selected by the sponsor according to predefined criteria. This approach aims to ensure the registry has appropriate clinical expertise and data capture capabilities for the specific device and indication.
What evidence is described
The entry provides device details and patient conditions but does not present trial outcomes in this listing. It describes a data collection framework designed to monitor safety and performance signals within a European registry.
FAQ
- What is the focus of this registry update? It describes conditions, device and enrollment details with invitation only enrollment.
- Who may participate in the registry? Sites and investigators invited by the sponsor.
- Where can I find the official registration? See the ClinicalTrials.gov entry NCT07395219.
Conclusion
In summary the European Transoral incisionless fundoplication 2.0 registry defines a defined data collection approach for GERD and LPR using the EsophyX device. Stakeholders should align with MDR Annex XIV expectations and closely follow registry updates from the sponsor.
Disclaimer
For professionals this material is not legal advice. Regulatory interpretation should rely on counsel and current MDR guidance.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07395219?term=medical+device