Intra Abdominal PressureNCT07400666
Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion IAP Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.
A study testing digital capsule in people with Intra Abdominal Pressure and Intra-Abdominal Hypertension, run by Dotspace Inc..
Trial summary
The proposed clinical study protocol is intended to establish the safety, utility, and reliability of using a pressure-sensing capsule present in a patient's gastrointestinal tract for monitoring intraabdominal pressure (IAP). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Intra Abdominal Pressure, Intra-Abdominal Hypertension
- What is being tested?
- digital capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The patient is anticipated to undergo an MRI examination within seven days after ingestion of the capsule.
- The patient is anticipated to undergo radiotherapy within seven days after ingestion of the capsule.
- Patients who are on ECMO treatment.
- 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.
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- 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.
- Patients with obvious clinical evidence of gastrointestinal tract obstruction or severe paralytic ileus that need immediate surgical intervention.
- 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 active implanted device, such as a cardiac pacemaker or other implanted electromedical devices.
- 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).
- Patients with Crohn's disease or diverticulitis.
- Patients diagnosed with radiation enteritis.
- 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.
- 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
- 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.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion Intra-abdominal Pressure Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.
The proposed clinical study protocol is intended to establish the safety, utility, and reliability of using a pressure-sensing capsule present in a patient's gastrointestinal tract for monitoring intraabdominal pressure (IAP). Monitoring IAP in critically ill patients is common in patients admitted to the ICU following a wide variety of surgical interventions. It has been reported that approximately 50% of critically ill patients will develop intraabdominal hypertension (IAH; defined as an IAP >12 mmHg) while in the ICU, which can be life-threatening due to complications resulting from organ dysfunction, organ failure, impaired ventilation and hemodynamic instability. When IAH is persistent and elevated above 20 mmHg the condition is identified as "Abdominal Compartment Syndrome (ACS)", which necessitates close monitoring of patients with IAH in order to reduce the development of ACS. IAP measurements based on technologies employing the bladder, gastric, inferior vena cava, rectal, vaginal and direct intraperitoneal placements have been reported for assessing IAP. However, the gold standard method for monitoring IAP is the use of an intravesical (bladder) Foley catheter manometric technique. PressureDOT® (Dotspace Inc.) is the investigational pressure-sensing capsule that will be assessed in a parallel device clinical study protocol performed in the same patient.
- Being tested
- digital capsule
- Keywords
- comparison study, Digital capsule
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital capsuleDevice
A digital capsule to monitor intra-gastrointestinal pressure and wirelessly transmit the data to bedside reader for healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients who require IAP monitoring | Experimental | The subject will have PressureDOT and Centurion IAP monitoring device to collect the IAP data at the same time in the study until the excretion of digital capsule. Receives: Device: digital capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo grade.
Measured: From deployment of the PressureDOT digital capsule to the 7 days after the digital capsule excretion.
The agreements of two IAP measurement devices.
Measured: From the deployment of the PressureDOT digital capsule to 7 days after the digital capsule excretion.
The average time to excrete the PressureDOT digital capsule in the enrolled study participants.
Measured: From the deployment of the PressureDOT digital capsule to 7 days after the digital capsule excretion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra Abdominal PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dotspace Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400666
- Sponsor's protocol ID
- PDT-02-012 V.2025-A.05
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We will discuss with the clinical sites and PIs for the next steps.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion Intra-abdominal Pressure Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.
- ClinicalTrials.gov ID
- NCT07400666
- Acronym / sponsor ID
- PDT-02-012 V.2025-A.05
- Keywords
- comparison study, Digital capsule
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Dotspace Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed clinical study protocol is intended to establish the safety, utility, and reliability of using a pressure-sensing capsule present in a patient's gastrointestinal tract for monitoring intraabdominal pressure (IAP). Monitoring IAP in critically ill patients is common in patients admitted to the ICU following a wide variety of surgical interventions. It has been reported that approximately 50% of critically ill patients will develop intraabdominal hypertension (IAH; defined as an IAP >12 mmHg) while in the ICU, which can be life-threatening due to complications resulting from organ dysfunction, organ failure, impaired ventilation and hemodynamic instability. When IAH is persistent and elevated above 20 mmHg the condition is identified as "Abdominal Compartment Syndrome (ACS)", which necessitates close monitoring of patients with IAH in order to reduce the development of ACS. IAP measurements based on technologies employing the bladder, gastric, inferior vena cava, rectal, vaginal and direct intraperitoneal placements have been reported for assessing IAP. However, the gold standard method for monitoring IAP is the use of an intravesical (bladder) Foley catheter manometric technique. PressureDOT® (Dotspace Inc.) is the investigational pressure-sensing capsule that will be assessed in a parallel device clinical study protocol performed in the same patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients who require IAP monitoring | Experimental | Device: digital capsuleThe subject will have PressureDOT and Centurion IAP monitoring device to collect the IAP data at the same time in the study until the excretion of digital capsule. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (26 listed)
- The patient is anticipated to undergo an MRI examination within seven days after ingestion of the capsule.
- The patient is anticipated to undergo radiotherapy within seven days after ingestion of the capsule.
- Patients who are on ECMO treatment.
- Conscious patients with a history of difficulty with swallowing due to functional or anatomic disorder.
- Patients with a history of bowel stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital capsuleA digital capsule to monitor intra-gastrointestinal pressure and wirelessly transmit the data to bedside reader for healthcare providers. | Device | ICU patients who require IAP monitoring |
Primary outcome
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo grade.
Time frame: From deployment of the PressureDOT digital capsule to the 7 days after the digital capsule excretion.
The agreements of two IAP measurement devices.
Time frame: From the deployment of the PressureDOT digital capsule to 7 days after the digital capsule excretion.
The average time to excrete the PressureDOT digital capsule in the enrolled study participants.
Time frame: From the deployment of the PressureDOT digital capsule to 7 days after the digital capsule excretion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided. We will discuss with the clinical sites and PIs for the next steps.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing digital capsule in people with Intra Abdominal Pressure and Intra-Abdominal Hypertension, run by Dotspace Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao-Hsin Chou, Medical Doctor (+886-910-089-124, johnsonchou@dotspaceinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo grade. (time frame: From deployment of the PressureDOT digital capsule to the 7 days after the digital capsule excretion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.