G-POEM + GES for Gastroparesis

This trial tests two treatments for severe gastroparesis: G-POEM (Gastric Peroral Endoscopic Myotomy) and GES (Gastric Electrical Stimulation). Gastroparesis prevents the stomach from emptying food properly. Researchers aim to assess the safety and effectiveness of each treatment individually and in combination. The trial targets individuals with gastroparesis symptoms unresponsive to medication for over a year. Participants must have a confirmed diagnosis of delayed stomach emptying. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for gastroparesis.

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that G-POEM, a procedure that aids food movement through the stomach, is generally safe for treating gastroparesis, a condition where food moves too slowly through the stomach. Studies indicate that G-POEM is almost always technically successful and safe for most patients who haven't improved with other treatments. While some individuals may still experience symptoms, many feel better after the procedure.

Researchers are excited about these treatments for gastroparesis because they offer new approaches to managing this challenging condition. Unlike traditional treatments like dietary changes and medications that mainly focus on symptom relief, G-POEM (Gastric Per-Oral Endoscopic Myotomy) directly targets the pyloric muscle to improve gastric emptying. This new mechanism of action could provide more effective relief for patients. Additionally, when combined with Gastric Electrical Stimulation (GES), there is potential for enhanced symptom control and improved quality of life. These innovative approaches could present significant advantages over existing treatments by addressing the root cause of the condition rather than just alleviating symptoms.

This trial will compare different treatment approaches for gastroparesis. Studies have shown that G-POEM, a procedure involving a small cut in the stomach lining to improve function, is quite effective, with success rates between 60.5% and 98.6%. Research indicates that patients often experience significant relief, with some studies noting improvements lasting up to 4 years. G-POEM has a strong track record, particularly for patients unresponsive to other treatments. In this trial, some participants will receive G-POEM alone, while others will receive GES, a treatment using electrical pulses to aid the stomach, alone. Additionally, a combination arm will provide both G-POEM and GES. Evidence suggests these methods effectively relieve symptoms, and the combination might be especially beneficial for severe cases. Overall, both treatments show promise in alleviating gastroparesis symptoms.¹⁴⁶⁷⁸