Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT03056859
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2017-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compass Device CVC Trial
Sponsor:
University of New Mexico
Organization:
Study Overview
Official Title:
Central Venous Catheterization in Obese Patients With Compass Device
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This is a single-arm observational trial of a device (Compass Vascular Access, Centurion Medical Products, Williamston MI). The device is a compact, sterile, single-use extravascular blood pressure transducer. This pressure measurement aids in confirmation of appropriate venous access. The investigators plan to enroll 40 consenting patients with BMI ≥35 who require central venous catheterization for clinical reasons independent of the existence of this study. The primary outcome is operator satisfaction.
Detailed Description:
Forty (40) consenting patients meeting inclusion/exclusion criteria for this single-arm observational trial will be prepared as usual for central venous catheter (CVC) placement. The Compass pressure measurement device will be included in the CVC placement apparatus as per the manufacturer's directions. Data will be recorded on the placement procedure, operator satisfaction, routine patient demographics, and incidence of inadvertent arterial puncture.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: