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

February 3, 2026 updated by: Dotspace Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICU patients who require IAP monitoring
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.
Device: digital capsule
A digital capsule to monitor intra-gastrointestinal pressure and wirelessly transmit the data to bedside reader for healthcare providers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
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.
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.
From the deployment of the PressureDOT digital capsule to 7 days after the digital capsule excretion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dotspace Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDT-02-012 V.2025-A.05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will discuss with the clinical sites and PIs for the next steps.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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