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Enrolling by Invitation

NCT Number: NCT07395219

European TIF2.0 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).

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Key information

Conditions

Gastro -Oesophagal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngo-pharyngeal Reflux

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of General Surgery, Medical University of Vienna, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device

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

Primary outcomes

  1. 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.)

  2. 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.)

  3. 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

Secondary outcomes

  1. Physiological reflux testing

    Time frame: up to 5-years

    Change in pH physiological testing

  2. 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

  3. Procedural outcomes (duration)

    Time frame: 30-days

    Total length of the procedure in minutes

  4. Procedural outcomes (length of hospital stay

    Time frame: 30-days

    The time in days from procedure to discharge from hospital

  5. Adverse events

    Time frame: up to 30-days

    Adverse events (AE) following TIF2.0 according to the AGREE classification

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Cleveland Clinic London

Other

Registry information

Official study title

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

Acronym: EURO-TIF

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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