Enrolling by invitation NCT07395219
European TIF2.0 Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device.
- Who it may be relevant to
- Registry conditions: Gastro -Oesophagal Reflux, Laryngo-pharyngeal Reflux. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Italy, Serbia, Switzerland, Turkey (Türkiye) +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Evaluation of the Safety and Efficacy of Transoral Incisionless Fundoplication 2.0 in the Management of Reflux: a European Registry
Overview
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).
Interventions
- 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 rep
Primary outcome measures
- Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL) [Time frame: 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]
- Proton pump inhibitor and/or histamine-2 receptor antagonist use [Time frame: 6-months, 1-year, 2-years, 3-years, 5-years]
Secondary outcome measures (7)
- Physiological reflux testing [Time frame: up to 5-years]
- Procedural outcomes (technical success) [Time frame: 30-days]
- Procedural outcomes (duration) [Time frame: 30-days]
- Procedural outcomes (length of hospital stay [Time frame: 30-days]
- Adverse events [Time frame: up to 30-days]
- Adverse events of special interest [Time frame: Up to 5-years]
- Need for revisional procedure [Time frame: Up to 5-years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Department of General Surgery, Medical University of Vienna — Vienna
Italy · 1 center
- Gemelli Isola — Rome
Serbia · 1 center
- University Hospital for Digestive Surgery — Belgrade
Switzerland · 1 center
- Intesto — Bern
Turkey (Türkiye) · 1 center
- Memorial bahçelievler hospital — Istanbul
United Arab Emirates · 1 center
- Cleveland Clinic — Abu Dhabi
United Kingdom · 1 center
- Cleveland Clinic London — London
Publications
- 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
- 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
- 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
- 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
- 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
- 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. eC PMID 36618876
- 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
Identifiers
NCT: NCT07395219 · CCL-2021-TIF