PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends.
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Incidence of device-related or sensor insertion/removal procedure-related adverse events
Timeframe: 15 days
Rate of foreign body reaction due intra-gastrointestinal insertion
Timeframe: 15 days
Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus
Timeframe: 15 days
Incidence of sensor failure
Timeframe: 15 days