Wireless Gastrointestinal Motility Monitoring Systems

Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD

A Wireless Gastrointestinal Motility Monitoring System is an ingestible capsule with the trade name SmartPill ® . The SmartPill ® records data enabling the estimation of regional and total gastrointestinal motility. The device is Food and Drug Administration (FDA) approved to evaluate patients with suspected delayed gastric emptying and the evaluation of colonic transit time in patients with chronic idiopathic constipation. The capsule device measures pH, temperature, and pressure while traveling through the gastrointestinal (GI) tract, sending the data to a wireless receiver worn on or near the patient. The data can be used to determine GI motility, gastric emptying, small bowel transit, colonic transit, and whole gut transit times. The capsule can also provide pressure patterns within the GI tract. The study can be done in a physician office after the patient has discontinued use of all medications that affect the GI tract. Indications The Wireless Motility Capsule (WMC) has been studied in many centers. The capsule does not use radioactive materials and has minimal safety risks. Palmetto GBA will cover the device when: It is used by a gastroenterologist trained to use and interpret the results. It is used to evaluate and/or treat patients with suspected gastroparesis of any nature. It is used to evaluate colonic transit in patients with chronic idiopathic constipation lasting over 6 months. Basic clinical investigations, including endoscopy, have failed to elucidate a diagnosis. Limitations The WMC should not be administered to patients with a history of gastric bezoar, swallowing disorders, dysphagia, suspected strictures/fistulae in the GI tract, physiologic GI obstruction, GI surgery within the previous 3 months, Crohn’s disease, diverticulitis, or who have an implanted electromechanical medical device (such as pacemaker or infusion pump). The capsule is not FDA approved for use in children.