Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05781347

Stretta Versus Conservative Treatment

Led by Military University Hospital, Prague · Updated on 2025-01-07

50

Participants Needed

1

Research Sites

186 weeks

Total Duration

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AI-Summary

What this Trial Is About

Gastroesophageal reflux disease (GERD) is one of the most common diseases of the gastrointestinal tract. Obesity is a significant risk factor for GERD; however, treatment outcomes in obese patients remain challenging. In the Czech Republic, therapeutic options are currently limited to conservative treatment, including pharmacotherapy and lifestyle modifications, or surgical interventions, both of which have known limitations. Stretta is a minimally invasive endoscopic therapy using radiofrequency energy delivered to the esophagogastric junction (EGJ) and cardia, aimed at enhancing the antireflux barrier. This study evaluates the effectiveness and safety of the Stretta procedure compared to conservative treatment in managing GERD. Initially designed to compare outcomes between obese and non-obese populations, the study was expanded to include all GERD patients due to recruitment challenges and the need to meet strict eligibility criteria. These criteria ensure reliable results by focusing on patients with confirmed pathological GERD while excluding those with hiatal hernias ≥ 2 cm, severe esophagitis, or functional esophageal disorders such as hypersensitivity. The study aims to provide comprehensive data on the use of Stretta in the Czech Republic and its role in GERD management.

CONDITIONS

Official Title

Stretta Versus Conservative Treatment

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Verified symptomatic GERD despite PPI use, with persistent symptoms, desire to discontinue PPIs, or intolerance to them.
  • Pathological gastroesophageal reflux confirmed by positive 24-hour pH-metry with impedance.
  • Normal findings on high-resolution esophageal manometry according to CCv4.0.
  • Age 18 years or older.
  • Signed informed consent for participation in the trial and invasive procedures.
Not Eligible

You will not qualify if you...

  • Active severe reflux esophagitis (Los Angeles classification grade C or D).
  • Barrett's esophagus.
  • Esophageal peptic stricture or eosinophilic esophagitis.
  • Hiatal hernia 2 cm or larger.
  • Malignancies.
  • Abnormal findings on high-resolution esophageal manometry.
  • Esophageal or subcardial varices.
  • Pregnancy.
  • Severe comorbidities or increased perioperative risk.
  • Age over 70 years due to increased perioperative risk and common comorbidities.
  • Symptoms mainly related to functional dyspepsia, significant anxiety, or depression with overlap to other gut-brain interaction disorders.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Military University Hospital Prague

Prague, Czechia

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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