Novel Gas-Sensing Capsule May Provide New Tool for Assessing Motility Disorders

New research suggests the potential utility of a novel gas-sensing capsule for assessing regional transit time across multiple areas of the GI tract to diagnose motility disorders.

Findings highlight agreement between the gas-sensing capsule and a US Food and Drug Administration (FDA)-cleared wireless motility capsule in measuring both gastric emptying time and colonic transit time, suggesting the gas-sensing capsule may be a viable replacement for the now-discontinued wireless motility capsule.

“Diagnosing motility disorders is a unique process for a gastroenterologist because many patients present with complaints that are nonspecific… We feel obliged to make sure we're not missing any life-threatening causes, whether it be cancer, obstruction, inflammation, or ulcers. But once that's done, we're still not quite sure what could be contributing to the patient's problems,” Braden Kuo, MD, a neurogastroenterologist and director of the Center for Neurointestinal Health at Massachusetts General Hospital, explained to HCPLive.

In 2008, the FDA cleared Medtronic’s SmartPill for the functional assessment of the GI system and to assess conditions like gastroparesis, small bowel dysmotility, and colonic TT in chronic constipation. However, it was recently discontinued due to sourcing issues for the supplies necessary to produce the SmartPill, creating a need for a replacement.

“Fortunately, a new technology called Atmo, a gas-sensing capsule, has been developed to potentially replace the SmartPill. It works by measuring oxygen content and CO2 content as the capsule courses through the stomach, the small bowel, and the colon,” Kuo described. “By changes in these oxygen and CO2 concentrations, you can see and know where the capsule transitions from the stomach to the small bowel to the colon, thereby giving you a very distinct profile of the stomach residence time, the small bowel transit time, and the colon transit time so we can, in one ambulatory test, decide if they have gastroparesis, rapid gastric emptying, or constipation, and treat patients accordingly.”

To assess this novel gas-sensing capsule against the wireless motility capsule, Kuo and colleagues recruited individuals with upper, lower, or combined GI symptoms for a prospective multicenter study. Participants (n = 219) concomitantly ingested the gas-sensing capsule and wireless motility capsule in a randomized order. Regional transit times including gastric emptying time and colonic transit time were measured and compared between the devices, with gastric emptying time >5 hours and colonic transit time >59 hours being defined as delayed.

In total, 177 participants yielded paired gastric emptying time results and 147 had paired colonic transit time. Pearson correlation coefficients for gastric emptying time and colonic transit time comparisons between the capsules were 0.86 (0.81-0.89) and 0.74 (0.66-0.81), respectively.

Of note, gastric emptying time demonstrated a positive predicted value (PPV) of 78%, negative predictive value of 85.83%, and overall agreement of 83.62%. For colonic transit time, the PPV was 67.35%, the negative predictive value was 92.89%), and the overall agreement was 84.35%.

No serious adverse device effects were reported in the study. Among the total gastric emptying time, 32.2% had delayed gastric emptying time. Among the colonic transit time evaluable cohort, 27.2% had delayed colonic transit time. For the cohort that had measurements for all transit regions, 20% had delayed colonic transit time only, 11% had delayed gastric emptying time only, and 18% had a delay in multiple GI regions as measured by the gas-sensing capsule.

“It shows excellent correlation, above 80% in many situations, showing that this can potentially be used as a replacement for the SmartPill capsule. We're very excited about potentially having this FDA-approved and for clinical use in the future,” Kuo concluded.

Editors’ note: Kuo has relevant disclosures with ATMO, Phathom, and Takeda.

Reference

^{Kuo B, Lee A, Abell T, et al. Comparative Evaluation of Gas-Sensing Capsule and Wireless Motility Capsule for Transit Time Assessment in Motility Disorders. Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}