Image

Stretta Versus Conservative Treatment in Obese and Non-obese

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

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

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.