Key takeaways:

• The swallowed capsule detected the presence of blood with a sensitivity and specificity of 92.9% and 90.6%, respectively.
• Positive and negative predictive values were 74.3% and 97.9%.

The PillSense System, a novel blood-sensing swallowed capsule device, safely detected blood in patients with clinically suspected upper gastrointestinal bleeding with a sensitivity of 92.9% and a specificity of 90.6%, data showed.

“[Esophagogastroduodenoscopy] is now considered the gold standard for diagnosing and treating [upper GI bleeding (UGIB)], although timely diagnosis and intervention can be challenging from a time, personnel and access perspective,” Karl Akiki, MD, a research fellow in the division of gastroenterology and hepatology at Mayo Clinic College of Medicine and Science, and colleagues wrote in Gastrointestinal Endoscopy. “Hence, an accurate, rapid, easy-to-interpret and noninvasive tool could assist in both diagnosing and offering guidance for clinical decision-making in scenarios of a suspected UGIB.”

In an open-label, single-arm, comparative clinical trial, Akiki and colleagues evaluated the safety and efficacy of the PillSense System (EnteraSense Ltd.), an ingestible capsule that detects blood in the upper GI tract via an optical sensor and transmits data to an external receiver.

They enrolled 126 adults (mean age, 62.4 years; 59.5% men) with suspected UGIB at Mayo Clinic in Rochester between December 2021 and August 2022. Participants underwent esophagogastroduodenoscopy (EGD) within 4 hours of capsule administration and were monitored up to 21 days to confirm capsule passage.

According to results, 110 patients (87.3%) had confirmed capsule passage, with a mean transit time of 3.6 days. The capsule correctly detected the presence of blood in 26 out of 28 cases and the absence of blood in 87 out of 96 cases compared with EGD. The mean PillSense recording time was 6.71 minutes.

Further analysis demonstrated a sensitivity and specificity of 92.9% (95% CI, 76.5-99.1) and 90.6% (95% CI, 82.9-95.6), respectively, as well as positive and negative predictive values of 74.3% and 97.8%. The positive and negative likelihood ratios were 9.9 and 0.08.

Researchers reported no adverse events related to the PillSense System or capsule ingestion.

“Our study demonstrates that a novel blood-sensing swallowed capsule device provides highly accurate and rapid detection of UGIB,” Akiki and colleagues concluded. “The device was simple to deploy, results were easy to interpret and the capsule passed safely through the GI tract in all patients that completed the study.”

They continued: “The PillSense System may assist in efficiently diagnosing UGIB with the goal of improving patient outcomes and may ultimately alter the diagnostic and treatment approach for patients with a suspected UGIB.”