Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion IAP Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.

Prior treatment

• The patient is anticipated to undergo radiotherapy within seven days after ingestion of the capsule.
• Patients with obvious clinical evidence of gastrointestinal tract obstruction or severe paralytic ileus that need immediate surgical intervention.
• Patients diagnosed with radiation enteritis.

Other illness

• Conscious patients with a history of difficulty with swallowing due to functional or anatomic disorder.
• Patients with a history of bowel stenosis.
• Patients with a history of bowel mechanical obstruction.
• Patients with a past history of intestinal diverticula, intestinal obstruction/stenosis, intestinal reconstructed operation or any past history indicating a high risk for capsule retention based on the PI's evaluation and judgement.
• The presence of any other active implanted device, such as a cardiac pacemaker or other implanted electromedical devices.
• Patients with Crohn's disease or diverticulitis.
• Patients with severe systemic diseases and not allowed to join this study by the principal investor's judgement, such as severe congestive heart failure, renal failure or liver diseases.
• Subjects with any contraindication to urinary bladder catheterization or intravesical intra-abdominal pressure measurement, including but not limit:
  • Known or suspected urethral injury, severe urethral stricture or recent pelvic or lower urinary tract trauma.
  • Recent urological surgery involving the bladder, prostate, or urethra that precludes safe Foley catheter placement.
  • Clinically diagnosed urosepsis or active, symptomatic urinary tract infection.
  • Neurogenic bladder with documented poor bladder compliance, in the judgment of the Principal Investigator.
  • Confirmed anuria or urinary obstruction that may compromise the accuracy or safety of intravesical pressure measurement.
  • Gross hematuria or bladder outlet obstruction that contraindicates Foley catheterization.

Other

• The patient is anticipated to undergo an MRI examination within seven days after ingestion of the capsule.
• Patients who are on ECMO treatment.
• Female subjects who are pregnant, planning on becoming pregnant or nursing. To exclude the possibility of pregnancy risk in the enrollment stage, a pregnancy test will be prescribed to the female subjects who fits the fertility status.
• The presence of any other wireless sensor or transmitter located in the abdomen (excluding compatible devices also in use for pressure sensing within the body).
• Congenital anomalies of gastrointestinal tract or any other anatomical abnormality of the head, neck, chest, or abdomen that would be a contraindication to placement of the PressureDOT® device and usage of the external device.
• Has a BMI \> 35 kg/m² or \<18.5 kg/m²
• A patient who, in the judgment of the Principal Investigator, is not appropriate for enrollment.
• A patient or his/her legal representative/surrogate who isn't fluent in English.
• A patient or his/her legal representative/surrogate who doesn't sign the Informed Consent.

• Patients admitted to the ICU who require IAP monitoring.
• Are at least 22 years old.
• Have a BMI greater than 18.5 kg/m², but less than 35 kg/m².
• Expected survival of at least 5 days.
• Blood sodium \> 130 and \< 150 mmol/L.
• Are able to speak and read English.
• Have signed an Informed Consent or their legal representative/surrogate has signed an Informed Consent.