Stretta Versus Conservative Treatment

ConditionGERD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMilitary University Hospital, Prague

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency Energy to the LES (Stretta Procedure)

    Procedure/Surgery

    The Stretta procedure is an endoscopic treatment performed under general anesthesia. It utilizes radiofrequency (RF) energy delivered to the lower esophageal sphincter (LES) and the gastric cardia to enhance the antireflux barrier.

  • Stretta

    Device

    Stretta is a FDA approved device for the management of GERD.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Patients receiving StrettaActive comparator 2 interventions
Group B: Patients receiving Conservative therapy/PPINo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proton pump inhibitors (PPI) use

Cessation or reducing the dose of PPI by at least 50% from baseline

Time frame
6 months
2

Proton pump inhibitors (PPI) use

Cessation or reducing the dose of PPI by at least 50% from baseline

Time frame
12 months
3

GERD Health Related Quality of Life questionaire

Change in symptom severity assessed by validated reflux questionnaire

Time frame
6 months
4

GERD Health Related Quality of Life questionaire

Change in symptom severity assessed by validated reflux questionnaire (GERD - HRQL)

Time frame
12 months

Secondary outcomes

1

24h pH-metry with impedance

Change in pH-metric parameters (Acid Exposure Time - AET)

Time frame
6 months
2

24h pH-metry with impedance

Change in pH-metric parameters (Acid Exposure Time - AET)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.