Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis

Launched by EVANGELIC HOSPITAL KALK COLOGNE · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical treatment for gastroparesis, a condition that affects how the stomach moves food into the intestines, causing symptoms like bloating, nausea, and abdominal pain. The trial is focused on a device called the Enterra® system, which acts like a pacemaker for the stomach, sending mild electrical pulses to help improve stomach function and reduce symptoms. Researchers want to see how well this treatment works, how it affects patients' quality of life, and whether it leads to fewer hospital visits.

To participate in this study, you need to be between 18 and 74 years old and have been diagnosed with gastroparesis that hasn’t improved with other treatments. You should also be experiencing significant difficulties in your daily life due to the condition. If you qualify and choose to join, you would receive the gastric pacemaker through a minimally invasive surgery, and the team will monitor your symptoms and overall health before and after the procedure to see how it helps you. If you have any questions about the trial or your eligibility, don't hesitate to reach out to the study team for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Scintigraphically proven gastroparesis
• • Failed conservative therapy
• • Severe impairment of quality of life
• • Written informed consent
• • German language
• Exclusion Criteria:
• • Age \< 18 years
• • Prior gastric resection