A phase 3, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an anti-reflux valve (with video).

The SEMS-V stent was equally effective in relieving dysphagia as compared with SEMS-NV stent. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents implying either, that the valve was not effective, or that all patients being on PPIs could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended.