GERDNCT05781347
Stretta Versus Conservative Treatment
A study testing Radiofrequency Energy to the LES (Stretta Procedure) and Stretta in people with GERD, run by Military University Hospital, Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GERD
- What is being tested?
- Radiofrequency Energy to the LES (Stretta Procedure) and Stretta
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2022to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Treatment of Gastro-esophageal Reflux Disease With Application of Radiofrequency Energy to the Lower Esophageal Sphincter (Stretta) Versus Conservative Treatment, Prospective Randomized Study
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.
Read the 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
- Being tested
- Radiofrequency Energy to the LES (Stretta Procedure), Stretta
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Energy to the LES (Stretta Procedure)Procedure or 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.
StrettaDevice
Stretta is a FDA approved device for the management of GERD.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Stretta | Active comparator | Not described Receives: Procedure: Radiofrequency Energy to the LES (Stretta Procedure); Device: Stretta |
| Patients receiving Conservative therapy/PPI | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proton pump inhibitors (PPI) use
Cessation or reducing the dose of PPI by at least 50% from baseline
Measured: 6 months
Proton pump inhibitors (PPI) use
Cessation or reducing the dose of PPI by at least 50% from baseline
Measured: 12 months
GERD Health Related Quality of Life questionaire
Change in symptom severity assessed by validated reflux questionnaire
Measured: 6 months
GERD Health Related Quality of Life questionaire
Change in symptom severity assessed by validated reflux questionnaire (GERD - HRQL)
Measured: 12 months
Reflux Severity Index score
Change in symptom severity assessed by validated reflux questionnaire
Measured: 6 months
Reflux Severity Index score
Change in symptom severity assessed by validated reflux questionnaire
Measured: 12 months
Secondary outcomes (2)
24h pH-metry with impedance
Change in pH-metric parameters (Acid Exposure Time - AET)
Measured: 6 months
24h pH-metry with impedance
Change in pH-metric parameters (Acid Exposure Time - AET)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Sep 2022
- Primary completion1 Aug 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized (ratio 1:1) into two groups: one receiving the Stretta therapy and the other undergoing conservative treatment with proton pump inhibitors (PPIs). The initial plan to stratify patients into obese and non-obese groups was revised due to recruitment challenges. The study now includes all eligible patients with gastroesophageal reflux disease (GERD), regardless of body weight, provided they meet the inclusion criteria.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katerina Kostalova, MD, Military University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781347
- Sponsor's protocol ID
- 108/17-12/2022
- Status last verified
- Jan 2025
- First submitted
- 16 Feb 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Gastro-esophageal Reflux Disease With Application of Radiofrequency Energy to the Lower Esophageal Sphincter (Stretta) Versus Conservative Treatment, Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05781347
- Acronym / sponsor ID
- 108/17-12/2022
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Military University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized (ratio 1:1) into two groups: one receiving the Stretta therapy and the other undergoing conservative treatment with proton pump inhibitors (PPIs). The initial plan to stratify patients into obese and non-obese groups was revised due to recruitment challenges. The study now includes all eligible patients with gastroesophageal reflux disease (GERD), regardless of body weight, provided they meet the inclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Stretta | Active comparator | Procedure: Radiofrequency Energy to the LES (Stretta Procedure), Device: Stretta |
| Patients receiving Conservative therapy/PPI | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Patients receiving Stretta |
| StrettaStretta is a FDA approved device for the management of GERD. | Device | Patients receiving Stretta |
Primary outcome
Proton pump inhibitors (PPI) use
Time frame: 6 months
Cessation or reducing the dose of PPI by at least 50% from baseline
Proton pump inhibitors (PPI) use
Time frame: 12 months
Cessation or reducing the dose of PPI by at least 50% from baseline
GERD Health Related Quality of Life questionaire
Time frame: 6 months
Change in symptom severity assessed by validated reflux questionnaire
GERD Health Related Quality of Life questionaire
Time frame: 12 months
Change in symptom severity assessed by validated reflux questionnaire (GERD - HRQL)
Reflux Severity Index score
Time frame: 6 months
Change in symptom severity assessed by validated reflux questionnaire
Reflux Severity Index score
Time frame: 12 months
Change in symptom severity assessed by validated reflux questionnaire
2 secondary outcomes
24h pH-metry with impedance
Time frame: 6 months
24h pH-metry with impedance
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Energy to the LES (Stretta Procedure) and Stretta in people with GERD, run by Military University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proton pump inhibitors (PPI) use (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.