Gastric Electrical Stimulation for Gastroparesis

(HEAL Trial)

This trial explores new ways to use the Enterra™ device, which assists people with gastroparesis—a condition causing delayed stomach emptying, nausea, vomiting, and abdominal pain. Although the device already reduces nausea and vomiting, the study aims to determine if different settings of gastric electrical stimulation can also alleviate abdominal pain. Participants will have their device adjusted to one of three settings to identify which is most effective at reducing pain and improving quality of life. This trial may suit those who have had an Enterra™ device for at least eight weeks and experience daily abdominal pain from gastroparesis.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment settings that may enhance quality of life.

The trial information does not specify whether you need to stop taking your current medications. However, daily opioid use is not allowed, so you would need to stop those if applicable.

Research has shown that gastric electrical stimulation (GES) is generally safe for treating gastroparesis. Studies indicate that GES can help reduce symptoms like nausea and vomiting. The FDA has approved the Enterra™ neurostimulator for these symptoms, suggesting its safety for use.

However, the device carries some risks. Common issues include infection, pain at the implantation site, or the device pressing against the skin. Despite these potential problems, long-term studies suggest that GES is generally well-tolerated. Most patients experience improvements in symptoms and quality of life without major side effects.

Gastric Electrical Stimulation (GES) is unique because it uses electrical pulses to stimulate the stomach, potentially offering a new way to manage gastroparesis, a condition that slows or stops food movement from the stomach to the small intestine. Unlike most treatments that rely on medication to control symptoms, GES targets the stomach muscles directly. Researchers are excited about these treatments because they explore different stimulation patterns, such as continuous and short-cycle pulses, which might improve symptoms more effectively than current options. By focusing directly on the stomach's electrical activity, GES could offer a more targeted and possibly quicker relief for patients suffering from this challenging condition.

This trial will compare different gastric electrical stimulation (GES) parameters for treating gastroparesis. Studies have shown that GES can significantly help people with this condition. Specifically, research indicates that GES reduces symptoms like nausea and vomiting. A review of studies involving 601 patients confirmed that GES positively impacts symptom control. In some studies, improvement rates ranged from 45% to 90%. Additionally, GES has been linked to a better quality of life and less frequent vomiting. However, while GES works well for many, individual results can vary.¹⁶⁷⁸⁹