Focus of the Report: The focus of this Health Technology Assessment is to evaluate the effectiveness and safety of the Stretta radiofrequency (RF) procedure to treat gastroesophageal reflux disease (GERD) in adults.
Technology Description: Treatment with the Stretta is a minimally invasive procedure in which a flexible tube is introduced through the mouth and down the throat to the junction of the esophagus and stomach. Low-power low-temperature RF energy is applied to the lower esophageal sphincter muscle and the gastric cardia, which thickens the muscle and increases the size and number of smooth muscle fibers in the area. This restores the natural barrier function of the esophagogastric junction and reduces reflux. Although RF energy is delivered, the temperature delivered to the mucosa does not exceed 49 degrees Celsius.
Controversy: Laparoscopic fundoplication (of complications, such as GERD recurrence, need for repeat surgery, chronic dysphagia, gas, bloating, and inability to belch or vomit. Stretta is a minimally invasive procedure that leaves no scar and maintains the physical anatomy and function of the esophagus. While Stretta is less invasive than LF and may, therefore, result in fewer complications, it is unknown whether Stretta is equally effective, particularly in the long term.
Key Questions:
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Is Stretta RF treatment effective for the treatment of GERD in adults?
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How does Stretta RF treatment compare with other treatments for GERD?
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Is Stretta RF treatment in patients with GERD safe?
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Have definitive patient selection criteria been identified for Stretta RF treatment for GERD?
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