BlueCross BlueShield of Tennessee Medical Policy Manual

Ingestible pH and Pressure Capsule


Ingestible pH and pressure-sensing capsules (e.g., SmartPillĀ® GI Monitoring System) have been developed as a means of evaluating gastric emptying. The primary component is a wireless device that is equipped with pH, pressure, and temperature sensors. Once ingested, the device transmits pH, pressure, and temperature data to an external receiver that the individual wears as a belt. This device does not collect pictures. Gastric emptying is signaled when the pH monitor in the capsule indicates a change in pH from the acidic environment of the stomach to the alkaline environment of the small intestine. While the pH and pressure-sensing capsule does not measure 50% emptying time, it can be correlated with the scintigraphically measured 50% emptying time. The capsule also measures pressure and temperature throughout its transit through the entire gastrointestinal tract, allowing calculations of total gastrointestinal transit time. This technology is evaluated as a means to diagnosis suspected gastrointestinal (GI) motility disorders such as gastroparesis, intestinal dysmotility, and constipation.

Gastroparesis is a chronic disorder characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms of gastroparesis are often nonspecific and may mimic other gastrointestinal disorders. It can be caused by many conditions; most commonly it is idiopathic, diabetic or post-surgical. The test considered the reference standard for gastroparesis is called gastric emptying scintigraphy. The individual ingests a radionuclide-labeled standard meal, and then images are performed at 0, 1, 2, and 4 hours postprandial to measure how much of the meal has passed beyond the stomach. A typical threshold to indicate abnormal gastric emptying is more than 10% of the meal remaining at 4 hours after ingestion.




The evidence to date is lacking on the clinical utility of testing. It is not possible to determine whether there is net improvement in health outcomes using wireless ingestible pH and pressure-sensing capsules versus standard diagnostic tests.  Larger studies are needed that compare the results of the current conventional standard test for gastroparesis with those of the pH and pressure capsule.


Agency for Healthcare Research and Quality. (2013, May). Wireless motility capsule versus other diagnostic technologies for evaluating gastroparesis and constipation: a comparative effectiveness review. Retrieved February 17, 2016 from

American College of Gastroenterology. (2013, January). Clinical guideline: management of gastroparesis. Retrieved February 17, 2016 from

American Gastroenterological Association. (2013). American Gastroenterological Association medical position statement on constipation. Retrieved October 18, 2017 from the

Arora, Z., Parungao, J.M., Lopez, R., Heinlein, C., Santisi, J., & Birgisson, S. (2015). Clinical utility of wireless motility capsule in patients with suspected multiregional gastrointestinal dysmotility. Digestive Diseases and Sciences, 60 (5), 1350-1357. Abstract retrieved February 17, 2016 from PubMed database.

BlueCross BlueShield Association. Evidence Positioning System. (11:2017). Ingestible pH and pressure capsule. (2.01.81). Retrieved October 1, 2018 from .  (16 articles and/or guidelines reviewed)

Green, A.D., Belkind-Gerson, J., Surjanhata, B.C., Mousa, H., Kuo, B., & Di Lorenzo, C. (2013). Wireless motility capsule test in children with upper gastrointestinal symptoms. The Journal of Pediatrics, 162 (6), 1181-1187. Abstract retrieved February 17, 2016 from PubMed database.

Triadafilopoulos, G. (2016). Utility of wireless motility capsule and lactulose breath testing in the evaluation of patients with chronic functional bloating. BMJ Open Gastroenterology, 2016, 3: e000110. Doi:10.1136/bmjgast-2016-000110. (Level 4 evidence)

U.S. Food and Drug Administration. (2006, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053547. Retrieved September 23, 2009 from

U.S. Food and Drug Administration. (2009, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K092342. Retrieved August 16, 2011 from

Winifred S. Hayes, Inc. Medical Technology Directory. (2017, September). Wireless capsule systems for diagnosis of gastroparesis and monitoring of gastrointestinal motility. Retrieved October 19, 2017 from (55 articles and/or guidelines reviewed)




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