Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial
Background/Aims Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization. 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,...
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| Format: | Article |
| Language: | English |
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Korean Society of Gastrointestinal Endoscopy
2024-03-01
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| Series: | Clinical Endoscopy |
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| Online Access: | http://www.e-ce.org/upload/pdf/ce-2023-111.pdf |
| _version_ | 1797243250631770112 |
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| author | Lukas Bajer Marvin Ryou Christopher C. Thompson Pavel Drastich |
| author_facet | Lukas Bajer Marvin Ryou Christopher C. Thompson Pavel Drastich |
| author_sort | Lukas Bajer |
| collection | DOAJ |
| description | Background/Aims Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization. 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. Methods 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. Results 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 to a range from 2.8 to 4, indicating that each sensor capsule 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. Conclusions 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. |
| first_indexed | 2024-04-24T18:52:08Z |
| format | Article |
| id | doaj.art-ce6371976f86493e86f7c09b66b98182 |
| institution | Directory Open Access Journal |
| issn | 2234-2400 2234-2443 |
| language | English |
| last_indexed | 2024-04-24T18:52:08Z |
| publishDate | 2024-03-01 |
| publisher | Korean Society of Gastrointestinal Endoscopy |
| record_format | Article |
| series | Clinical Endoscopy |
| spelling | doaj.art-ce6371976f86493e86f7c09b66b981822024-03-26T23:27:55ZengKorean Society of Gastrointestinal EndoscopyClinical Endoscopy2234-24002234-24432024-03-0157220320810.5946/ce.2023.1117825Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trialLukas Bajer0Marvin Ryou1Christopher C. Thompson2Pavel Drastich3 Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic EnteraSense Limited, Galway, Ireland EnteraSense Limited, Galway, Ireland Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Prague, Czech RepublicBackground/Aims Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization. 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. Methods 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. Results 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 to a range from 2.8 to 4, indicating that each sensor capsule 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. Conclusions 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.http://www.e-ce.org/upload/pdf/ce-2023-111.pdfcapsulesgastrointestinal hemorrhagetriage |
| spellingShingle | Lukas Bajer Marvin Ryou Christopher C. Thompson Pavel Drastich Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial Clinical Endoscopy capsules gastrointestinal hemorrhage triage |
| title | Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial |
| title_full | Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial |
| title_fullStr | Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial |
| title_full_unstemmed | Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial |
| title_short | Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial |
| title_sort | novel upper gastrointestinal bleeding sensor capsule a first human feasibility and safety trial |
| topic | capsules gastrointestinal hemorrhage triage |
| url | http://www.e-ce.org/upload/pdf/ce-2023-111.pdf |
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