New pill could replace catheters for monitoring dangerous abdominal pressure
NCT ID NCT07400666
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new swallowable capsule (PressureDOT®) that measures pressure inside the abdomen. It will be used in 26 ICU patients who already need pressure monitoring. The goal is to see if the capsule is safe and works as well as the standard method using a bladder tube.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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