Ingestible Ph And Pressure Capsule

An ingestible pH and pressure-sensing capsule (SmartPill GI Monitoring System) measures pH, pressure, and temperature changes to signify the passage of the capsule through portions of the gastrointestinal tract. It is proposed as a means of evaluating gastric emptying for diagnosis of gastroparesis, and colonic transit times for the diagnosis of slow-transit constipation. For individuals who have suspected disorders of gastric emptying or suspected slow-transit constipation who receive diagnostic testing with an ingestible pH and pressure capsule, the evidence includes studies of test characteristics and case series of patients who have undergone the test. Relevant outcomes are test validity, other performance measures, symptoms, functional outcomes, and health status measures. The available studies have provided some comparative data on the SmartPill ingestible pH plus pressure-sensing capsule and other techniques for measuring gastric emptying. This evidence primarily consists of assessments of concordance with available tests. Because the available tests (eg, gastric emptying scintigraphy) are imperfect criterion standards, it is not possible to determine the true sensitivity and specificity of SmartPill. The results of the concordance studies have revealed a moderate correlation with alternative tests, but have provided only limited additional data on the true accuracy of the test in clinical care. Evaluation of cases with discordant results would be of particular value and, ideally, these studies should be linked to therapeutic decisions and to meaningful clinical outcomes. The evidence to date on the clinical utility of testing is lacking, consisting of a small number of retrospective studies. It is not possible to determine whether there is net improvement in health outcomes using SmartPill vs standard diagnostic tests. The evidence is insufficient to determine the effects of the technology on health outcomes.