Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571786
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
SHAPE for ICP Assessment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Subharmonic Aided Pressure Estimation SHAPE for Intracranial Pressure ICP Assessment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Subharmonic Aided Pressure Estimation SHAPE technique is a noninvasive ultrasound-based imaging technique that can estimate ambient pressure using subharmonic emissions from ultrasound contrast agents Ultrasound contrast agents are encapsulated microbubbles mean diameter 8 µm with a lipid protein or polymer shell that traverse the entire vasculature When the contrast microbubbles are insonated with relatively high acoustic pressures 100-150 kPa these microbubbles act as nonlinear oscillators yielding energy components in the received echo signals at frequencies ranging from the subharmonic half of transmit frequency to higher harmonics and even ultraharmonics Based on empirical evidence the subharmonic signal exhibits a sigmoidal relationship with incident acoustic pressure ie subharmonic signal can be divided into occurrence growth and saturation stages In the growth stage the subharmonic signal has shown sensitivity to ambient pressure characterized by an inverse linear relationship between subharmonic signal and ambient pressure changes This inverse linear relationship forms the basis for the SHAPE technique Several pre-clinical and clinical studies have been conducted to utilize the SHAPE technique for in vivo pressure estimation eg to diagnose portal hypertension to estimate intra-cardiac pressures and to determine interstitial fluid pressures The core imaging mode underpinning the SHAPE technology subharmonic imaging is now available on some commercial scanners In the proposed pilot study the SHAPE technique will be leveraged for monitoring intracranial pressure ICP The use of SHAPE technique for the ophthalmic artery could potentially provide an accurate noninvasive method of measuring ICP in patients with idiopathic intracranial hypertension IIH and other conditions of raised ICP which would revolutionize the field
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None