By InvitationNot Applicable

European TIF2.0 Registry

Austria, Italy, Serbia500 participantsStarted 2023-01-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL)

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

Reflux symptom index (RSI)

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

Proton pump inhibitor and/or histamine-2 receptor antagonist use

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

Trial details

NCT IDNCT07395219

SponsorCleveland Clinic London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-01-01

View on ClinicalTrials.gov More Gastro -Oesophagal Reflux trials