Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial.

ABSTRACT:

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.

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

SUBMITTER: Bajer L 

PROVIDER: S-EPMC10984735 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature