Stretta Versus Conservative Treatment

NCT ID: NCT05781347

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-03-31

Brief Summary

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.

Detailed Description

Gastroesophageal reflux disease (GERD) is a significant clinical issue that substantially impairs patients' quality of life. Chronic symptoms such as heartburn, regurgitation, and chest pain, along with extraesophageal manifestations (e.g., laryngopharyngeal reflux), often drive patients-especially younger individuals-to seek effective treatment options. Many of these patients are motivated by the desire to reduce or eliminate long-term proton pump inhibitor (PPI) use, given concerns about potential side effects and dependence on medication.

The Stretta procedure, a minimally invasive endoscopic therapy using radiofrequency energy delivered to the esophagogastric junction (EGJ) and cardia, has shown promise in addressing these concerns by enhancing the antireflux barrier. This study aims to evaluate the effectiveness and safety of Stretta compared to conservative treatment in improving GERD management in the Czech Republic.

Initially, the study was designed to compare outcomes between obese and non-obese populations. However, due to recruitment challenges and the need for strict inclusion criteria, it was expanded to include all patients with confirmed pathological GERD. Participants are carefully selected based on stringent eligibility criteria, including pathological GERD confirmed by 24-hour pH-metry with impedance and exclusion of those with hiatal hernias ≥ 2 cm, severe esophagitis, or functional esophageal disorders such as esophageal hypersensitivity.

The primary goal of this study is to improve patients' quality of life and reduce the reliance on chronic PPI therapy. Secondary objectives include assessing the safety profile of the Stretta procedure and its effectiveness compared to conservative management in a broader GERD population. By focusing on these outcomes, the study seeks to provide valuable insights into the role of Stretta as a therapeutic option in GERD management and its potential to fill a critical gap in current treatment modalities.

Conditions

GERD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients receiving Stretta

Group Type: ACTIVE_COMPARATOR

Radiofrequency Energy to the LES (Stretta Procedure)

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

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

Patients receiving Conservative therapy/PPI

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Radiofrequency Energy to the LES (Stretta Procedure)

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.

Intervention Type: PROCEDURE

Stretta

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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 (HRM) according to CCv4.0.

Age ≥ 18 years. Signed informed consent for participation in the trial and invasive procedures.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Katerina Kostalova, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Military University Hospital Prague

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Facility Contacts

Katerina Kostalova, MD

Role: primary

katerina.kostalova@uvn.cz

+420973203076

Other Identifiers

108/17-12/2022

Identifier Type: -

Identifier Source: org_study_id