Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:37 AM
Study NCT ID:
NCT07400666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion IAP Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.
Sponsor:
Dotspace Inc.
Organization:
Study Overview
Official Title:
Intra-gastrointestinal Monitoring Device (PressureDOT®) and Centurion Intra-abdominal Pressure Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: