Good find. Fascinating study and encouraging results: “Patients reported better symptom control at 3 and 6 months compared to baseline on and off PPI. GERD-HRQL composite and individual question scores at 6 months were statistically significantly better than on- and off-PPI scores at baseline”.
But it did involve invasive procedures and there were several device / procedure related adverse events: “A total of 32 adverse events were reported in 14 patients. One adverse event was reported as “serious adverse event not related to the device or treatment.” The remaining 31 adverse events were not serious. Five events in four patients were reported as possibly or definitely device-related (three implant site pain, one localized infection, one dyspepsia) and seven events in six patients were reported as laparoscopic implant procedure-related (three implant site pain, three postoperative nausea, one localized infection). Not sure how they characterize two infections as “not serious”.
It will be interesting if the results can be confirmed in double blind, placebo-controlled studies.