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Stretta Versus Conservative Treatment in Obese and Non-obese

Stretta Versus Conservative Treatment in Obese and Non-obese

Recruiting
18 years and older
All
Phase N/A

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Overview

Gastroesophageal reflux disease (GERD) is one of the most common diseases of the gastrointestinal tract. One of the main risk factor is obesity. Currently, either conservative treatment including pharmacotherapy and lifestyle modifications or surgical treatment are the only therapeutic options available in the Czech Republic, both approaches having their known limitations. Stretta is a minimally invasive endoscopic therapy using the radiofrequency energy delivered to the EGJ and cardia to eventually enhance the antireflux barrier.

This study will attempt to get information regarding the treatment of GERD using Stretta in the Czech Republic and correlate results in obese and non-obese population.

Eligibility

Inclusion Criteria:

  • Verified symptomatic GERD using PPI but with persistent symptoms or like to discontinue or are intolerant to them
  • Positive 24h pH-metry for pathological GE reflux
  • Normal finding on HR esophageal manometry according to CCv4.0
  • Age over 18
  • Signed informed consent with the trial and invasive procedures

Exclusion Criteria:

  • Active severe reflux esophagitis (LA classification grade C - D)
  • Barrett's esophagus
  • Esophageal peptic stricture, eosinophilic esophagitis
  • Hiatal hernia more than 2 cm
  • Malignancies
  • Abnormal HR esophageal manometry
  • Esophageal and subcardial varices
  • Pregnancy
  • Severe comorbidities and increased perioperative risk

Study details
    GERD

NCT05781347

Military University Hospital, Prague

27 January 2024

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