Bajer Lukas, Ryou Marvin, C Thompson Christopher, Drastich Pavel
Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
EnteraSense Limited, Galway, Ireland.
Clin Endosc. 2024 Mar;57(2):203-208. doi: 10.5946/ce.2023.111. Epub 2024 Jan 17.
BACKGROUND/AIMS: Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization, and can be diagnosed by direct visualization. The present study aimed to evaluate the safety and feasibility of using the PillSense system (EnteraSense Ltd.), a novel diagnostic tool designed for the rapid in vivo detection of UGIB, in human volunteers.
In the present study, 10 volunteers swallowed a PillSense capsule, followed by 2 servings of an autologous blood preparation. Participants were monitored for capsule passage, overall tolerability of the procedure, and adverse events.
The procedure was completed per the protocol established in the present study in 9/10 cases. In 9 of the subjects, after capsule ingestion, the device indicated the absence of blood with sensor output values of 1. After the ingestion of the first blood mixture, the sensor outputs of all devices increased from 2.8 to 4, indicating that each camera detected blood. The sensor output remained within that range after the ingestion of the second mixture; however, in one case, the baseline capsule signal was positive, because of a preexisting condition. The passage of the capsule was verified in all patients, and no adverse events were reported.
The first trial of the PillSense system in human subjects demonstrated the feasibility, safety, and tolerability of utilizing this product as a novel, noninvasive, and easy-to-use triage tool for the diagnosis of patients suspected of having UGIB.
背景/目的：上消化道出血（UGIB）是最常见的需要住院治疗的胃肠道疾病，可通过直接观察进行诊断。本研究旨在评估PillSense系统（EnteraSense有限公司）在人类志愿者中作为一种用于快速体内检测UGIB的新型诊断工具的安全性和可行性。
在本研究中，10名志愿者吞下一粒PillSense胶囊，随后服用两份自体血液制剂。对参与者进行胶囊通过情况、该操作的总体耐受性和不良事件的监测。
按照本研究制定的方案，10例中有9例完成了该操作。在9名受试者中，胶囊摄入后，设备显示无血液，传感器输出值为1。在摄入第一份血液混合物后，所有设备的传感器输出从2.8增加到4，表明每个摄像头都检测到了血液。摄入第二份混合物后，传感器输出保持在该范围内；然而，在1例中，由于先前存在的状况，胶囊的基线信号为阳性。所有患者的胶囊通过情况均得到证实，且未报告不良事件。
PillSense系统在人体受试者中的首次试验证明了将该产品作为一种用于诊断疑似UGIB患者的新型、非侵入性且易于使用的分诊工具的可行性、安全性和耐受性。
