European TIF2.0 Registry

NCT07395219 | Enrolling By Invitation FDA Device

• 1 other identifier: CCL-2021-TIF
• Study Type: observational
• Target: 500
• Locations: 7 countries
• Sites: 7

Brief Summary

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).

Conditions

Gastro -Oesophagal Reflux; Laryngo-pharyngeal Reflux

Keywords

TIF; cTIF; GORD; GERD; Endoscopic intervention; Endoscopy; reflux

Outcome Measures

Primary Outcomes (3)

• 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.)

  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.)

  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

  6-months, 1-year, 2-years, 3-years, 5-years

Secondary Outcomes (7)

• Physiological reflux testing

  up to 5-years

• Procedural outcomes (technical success)

  30-days

• Procedural outcomes (duration)

  30-days

• Procedural outcomes (length of hospital stay

  30-days

• Adverse events

  up to 30-days

Study Arms (1)

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

Interventions

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.

Also known as: TIF, cTIF

Patients with gastro-oesophageal reflux disease or laryngo-pharyngeal reflux

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• Cleveland Clinic London: lead

Study Sites (7)

Department of General Surgery, Medical University of Vienna

Vienna, Austria

Location

Gemelli Isola

Rome, Italy

Location

University Hospital for Digestive Surgery

Belgrade, Serbia

Location

Intesto

Bern, Switzerland

Location

Memorial bahçelievler hospital

Istanbul, Turkey (Türkiye)

Location

Cleveland Clinic

Abu Dhabi, United Arab Emirates

Location

Cleveland Clinic London

London, United Kingdom

Location

Related Publications (7)

• Testoni S, Hassan C, Mazzoleni G, Antonelli G, Fanti L, Passaretti S, Correale L, Cavestro GM, Testoni PA. Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis. Endosc Int Open. 2021 Feb;9(2):E239-E246. doi: 10.1055/a-1322-2209. Epub 2021 Feb 3.

  PMID: 33553587 BACKGROUND

• Demartini B, Nistico V, D'Agostino A, Priori A, Gambini O. Early Psychiatric Impact of COVID-19 Pandemic on the General Population and Healthcare Workers in Italy: A Preliminary Study. Front Psychiatry. 2020 Dec 22;11:561345. doi: 10.3389/fpsyt.2020.561345. eCollection 2020.

  PMID: 33414728 BACKGROUND

• Cristol DA, Evers DC. The impact of mercury on North American songbirds: effects, trends, and predictive factors. Ecotoxicology. 2020 Oct;29(8):1107-1116. doi: 10.1007/s10646-020-02280-7. Epub 2020 Sep 24.

  PMID: 32970279 BACKGROUND

• Rahimi Z, Ghorbani-Shahna F, Bahrami A. Design, Implementation, and Evaluation of Industrial Ventilation Systems and Filtration for Silica Dust Emissions from a Mineral Processing Company. Indian J Occup Environ Med. 2021 Oct-Dec;25(4):192-197. doi: 10.4103/ijoem.IJOEM_55_19. Epub 2021 Dec 31.

  PMID: 35197669 BACKGROUND

• Globig P, Willumeit-Romer R, Martini F, Mazzoni E, Luthringer-Feyerabend BJC. Slow degrading Mg-based materials induce tumor cell dormancy on an osteosarcoma-fibroblast coculture model. Bioact Mater. 2021 Dec 30;16:320-333. doi: 10.1016/j.bioactmat.2021.12.031. eCollection 2022 Oct.

  PMID: 35386318 BACKGROUND

• Jaruvongvanich VK, Matar R, Reisenauer J, Janu P, Mavrelis P, Ihde G, Murray M, Singh S, Kolb J, Nguyen NT, Thosani N, Wilson EB, Zarnegar R, Chang K, Canto MI, Abu Dayyeh BK. Hiatal hernia repair with transoral incisionless fundoplication versus Nissen fundoplication for gastroesophageal reflux disease: A retrospective study. Endosc Int Open. 2023 Jan 4;11(1):E11-E18. doi: 10.1055/a-1972-9190. eCollection 2023 Jan.

  PMID: 36618876 BACKGROUND

• Mattei C, Tricoire-Leignel H, Legros C, Lewis RJ, Molgo J. Editorial: Pharmacological Aspects of Ligand-Gated Ion Channels as Targets of Natural and Synthetic Agents. Front Neurosci. 2022 Apr 8;16:895299. doi: 10.3389/fnins.2022.895299. eCollection 2022. No abstract available.

  PMID: 35464319 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: February 9, 2026
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1); GB (1); TU (1); CH (1); SE (1); AU (1); IT (1)