digital capsule
DeviceA digital capsule to monitor intra-gastrointestinal pressure and wirelessly transmit the data to bedside reader for healthcare providers.
NCT Number: NCT07400666
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.
Trial opening soon.
Get Notified22 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A digital capsule to monitor intra-gastrointestinal pressure and wirelessly transmit the data to bedside reader for healthcare providers.
Time frame: From deployment of the PressureDOT digital capsule to the 7 days after the digital capsule excretion.
Time frame: From the deployment of the PressureDOT digital capsule to 7 days after the digital capsule excretion.
Time frame: From the deployment of the PressureDOT digital capsule to 7 days after the digital capsule excretion.
Contact information is provided by the study sponsor or research team.
Chao-Hsin Chou, Medical Doctor
CONTACT
Uei-Ming Jow, Ph.D.
CONTACT
Dotspace Inc.
Industry
Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion Intra-abdominal Pressure Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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