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

NCT07400666 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PDT-02-012 V.2025-A.05
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Intra-Abdominal Hypertension; Intra Abdominal Pressure

Keywords

comparison study; Digital capsule

Outcome Measures

Primary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by Clavien-Dindo grade.

  From deployment of the PressureDOT digital capsule to the 7 days after the digital capsule excretion.

• The agreements of two IAP measurement devices.

  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.

  From the deployment of the PressureDOT digital capsule to 7 days after the digital capsule excretion.

Study Arms (1)

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.

Device: digital capsule

Interventions

digital capsule DEVICE

A digital capsule to monitor intra-gastrointestinal pressure and wirelessly transmit the data to bedside reader for healthcare providers.

ICU patients who require IAP monitoring

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dotspace Inc.: lead

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chao-Hsin Chou, Medical Doctor

CONTACT

+886-910-089-124; johnsonchou@dotspaceinc.com

Uei-Ming Jow, Ph.D.

CONTACT

919-4577577; jow@dotspaceinc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02