European TIF2.0 Registry (EURO-TIF)

February 3, 2026 updated by: Cleveland Clinic London

Prospective Evaluation of the Safety and Efficacy of Transoral Incisionless Fundoplication 2.0 in the Management of Reflux: a European Registry

This is a European, multi-centre, prospective registry that aims to determine the safety and efficacy of transoral incisionless fundoplication, with or without concomitant hiatal hernia repair, for the treatment of patients with gastro-oesophageal reflux disease (GORD).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Department of General Surgery, Medical University of Vienna
  • Italy
      • Rome, Italy
        • Gemelli Isola
  • Serbia
      • Belgrade, Serbia
        • University Hospital for Digestive Surgery
  • Switzerland
      • Bern, Switzerland
        • Intesto
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Memorial Bahçelievler Hospital
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Cleveland Clinic
  • United Kingdom
      • London, United Kingdom
        • Cleveland Clinic London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with gastro-oesophageal reflux disease or laryngo-pharyngeal reflux undergoing transoral incisionless fundoplication with or without concomitant hiatal hernia repair

Description

Inclusion Criteria:

  • Any adult patient (≥18 years old) undergoing TIF2.0 or cTIF, at a participating centre, who can understand and sign the informed consent form, and is conducted in line with local institutional review board approval and recommendations.

Exclusion Criteria:

  • There are no specific exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with gastro-oesophageal reflux disease or laryngo-pharyngeal reflux
Device: Transoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device

Transoral Incisionless Fundoplication (TIF):

The TIF procedure is an endoscopic, minimally invasive intervention designed to reconstruct the gastro-oesophageal valve and restore its function as a reflux barrier, without external incisions. The procedure is performed transorally using the EsophyX device under general anaesthesia. The device enables the creation of a 270° to 300° esophagogastric fundoplication.

Concomitant TIF (cTIF):

The cTIF procedure combines a laparoscopic hiatal hernia repair with the TIF performed in the same session. Patients with a hiatal hernia greater than 2 cm undergo laparoscopic reduction and crural repair, followed immediately by the TIF procedure using the EsophyX device. This combined approach addresses both the anatomical defect of the hiatal hernia and the functional deficiency of the gastro-oesophageal valve.

Other Names:
  • TIF
  • cTIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL)
Time Frame: 6-months, 1-year, 2-year, 3-years, 5-, years

Change in reflux-specific quality of life questionnaires

(The GERD-HRQL used in the study is composed of 16 questions related to symptoms of heartburn, regurgitation, swallowing and overall satisfaction. Each question provides a scaled score between 0-5 (0=no symptoms, 5= Symptoms incapacitating to do daily activities) with a total score of 75.)
6-months, 1-year, 2-year, 3-years, 5-, years
Reflux symptom index (RSI)
Time Frame: 6-months, 1-year, 2-years, 3-years, 5-years

Change in reflux-specific quality of life questionnaire

(The RSI used in the study is composed of 9 questions related to atypical symptoms of reflux or 'LPR'. Each question provides a scaled score between 0-5 (0=no problems, 5=severe problems) with a total score of 45.)
6-months, 1-year, 2-years, 3-years, 5-years
Proton pump inhibitor and/or histamine-2 receptor antagonist use
Time Frame: 6-months, 1-year, 2-years, 3-years, 5-years
Change in acid suppression use
6-months, 1-year, 2-years, 3-years, 5-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological reflux testing
Time Frame: up to 5-years
Change in pH physiological testing
up to 5-years
Procedural outcomes (technical success)
Time Frame: 30-days
Defined as successful completion of all steps of the cTIF or TIF2.0 procedure in the same sitting
30-days
Procedural outcomes (duration)
Time Frame: 30-days
Total length of the procedure in minutes
30-days
Procedural outcomes (length of hospital stay
Time Frame: 30-days
The time in days from procedure to discharge from hospital
30-days
Adverse events
Time Frame: up to 30-days
Adverse events (AE) following TIF2.0 according to the AGREE classification
up to 30-days
Adverse events of special interest
Time Frame: Up to 5-years
Subjective reporting of dysphagia, excessive belching or inability to belch, significant bloating and/or distension, and persistent nausea and vomiting.
Up to 5-years
Need for revisional procedure
Time Frame: Up to 5-years
The need for repreat endoscopic or surgical intervention due to recurrence of symptoms, failure of procedure of adverse events
Up to 5-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Clinic London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCL-2021-TIF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared publicly. Data will be available only to investigators at participating study centers for the purpose of study coordination, monitoring, and analysis in accordance with the study protocol and applicable data protection regulations. Broader sharing of IPD is not planned due to confidentiality considerations and data use agreements established with participating institutions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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