Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07400666
Eligibility Criteria:
Inclusion Criteria:
1. Patients admitted to the ICU who require IAP monitoring.
2. Are at least 22 years old.
3. Have a BMI greater than 18.5 kg/m², but less than 35 kg/m².
4. Expected survival of at least 5 days.
5. Blood sodium \> 130 and \< 150 mmol/L.
6. Are able to speak and read English.
7. Have signed an Informed Consent or their legal representative/surrogate has signed an Informed Consent.
Exclusion Criteria:
1. The patient is anticipated to undergo an MRI examination within seven days after ingestion of the capsule.
2. The patient is anticipated to undergo radiotherapy within seven days after ingestion of the capsule.
3. Patients who are on ECMO treatment.
4. Conscious patients with a history of difficulty with swallowing due to functional or anatomic disorder.
5. Patients with a history of bowel stenosis.
6. Patients with a history of bowel mechanical obstruction.
7. 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.
8. Patients with obvious clinical evidence of gastrointestinal tract obstruction or severe paralytic ileus that need immediate surgical intervention.
9. 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.
10. The presence of any other active implanted device, such as a cardiac pacemaker or other implanted electromedical devices.
11. 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).
12. Patients with Crohn's disease or diverticulitis.
13. Patients diagnosed with radiation enteritis.
14. 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.
15. 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.
16. Has a BMI \> 35 kg/m² or \<18.5 kg/m²
17. Subjects with any contraindication to urinary bladder catheterization or intravesical intra-abdominal pressure measurement, including but not limit:
1. Known or suspected urethral injury, severe urethral stricture or recent pelvic or lower urinary tract trauma.
2. Recent urological surgery involving the bladder, prostate, or urethra that precludes safe Foley catheter placement.
3. Clinically diagnosed urosepsis or active, symptomatic urinary tract infection.
4. Neurogenic bladder with documented poor bladder compliance, in the judgment of the Principal Investigator.
5. Confirmed anuria or urinary obstruction that may compromise the accuracy or safety of intravesical pressure measurement.
6. Gross hematuria or bladder outlet obstruction that contraindicates Foley catheterization.
18. A patient who, in the judgment of the Principal Investigator, is not appropriate for enrollment.
19. A patient or his/her legal representative/surrogate who isn't fluent in English.
20. A patient or his/her legal representative/surrogate who doesn't sign the Informed Consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT07400666
Study Brief:
Protocol Section:
NCT07400666