An observational study in Gastro -Oesophagal Reflux and Laryngo-pharyngeal Reflux, sponsored by Cleveland Clinic London. Enrolling by invitation at 7 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Cleveland Clinic London · Observational
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).
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 500 is above the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Cleveland Clinic London is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with gastro-oesophageal reflux disease or laryngo-pharyngeal reflux undergoing transoral incisionless fundoplication with or without concomitant hiatal hernia repair
Exclusion Criteria:
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.
Also known as: TIF, cTIF
Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL)
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.)
Time frame: 6-months, 1-year, 2-year, 3-years, 5-, years
Reflux symptom index (RSI)
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.)
Time frame: 6-months, 1-year, 2-years, 3-years, 5-years
Proton pump inhibitor and/or histamine-2 receptor antagonist use
Change in acid suppression use
Time frame: 6-months, 1-year, 2-years, 3-years, 5-years
Physiological reflux testing
Change in pH physiological testing
Time frame: up to 5-years
Procedural outcomes (technical success)
Defined as successful completion of all steps of the cTIF or TIF2.0 procedure in the same sitting
Time frame: 30-days
Procedural outcomes (duration)
Total length of the procedure in minutes
Time frame: 30-days
Procedural outcomes (length of hospital stay
The time in days from procedure to discharge from hospital
Time frame: 30-days
Adverse events
Adverse events (AE) following TIF2.0 according to the AGREE classification
Time frame: up to 30-days
Adverse events of special interest
Subjective reporting of dysphagia, excessive belching or inability to belch, significant bloating and/or distension, and persistent nausea and vomiting.
Time frame: Up to 5-years
Need for revisional procedure
The need for repreat endoscopic or surgical intervention due to recurrence of symptoms, failure of procedure of adverse events
Time frame: Up to 5-years
Plan to share: No — 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.
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Cleveland Clinic London