Stretta Versus Conservative Treatment

Launched by MILITARY UNIVERSITY HOSPITAL, PRAGUE · Mar 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for gastroesophageal reflux disease (GERD), a common digestive condition that causes symptoms like heartburn and regurgitation. The trial is comparing a new procedure called Stretta, which uses gentle radiofrequency energy to strengthen the area that prevents stomach acid from flowing back up into the esophagus, to traditional treatments like medication and lifestyle changes. This research aims to understand how effective Stretta is for both obese and non-obese individuals suffering from GERD in the Czech Republic.

To participate in the trial, individuals must be over 18 years old and have symptoms of GERD that persist despite using medications. They must also have a confirmed diagnosis through specific tests. However, certain conditions, like severe esophageal issues or pregnancy, may prevent someone from joining the study. Those who take part can expect to undergo the Stretta procedure and be monitored for its effectiveness in relieving their GERD symptoms. This trial is important because it could offer a new option for people who struggle with GERD, especially those who are not finding relief with conventional treatments.

Gender

ALL

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).