Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569888
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Utility of Low Intensity Pulsed Ultrasound Stimulation LIPUS to Modulate the Release of Mediators Capable of Reflecting the Inflammatory State in the Affected Colonic Tract of Ulcerative Colitis Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Utility of Low Intensity Pulsed Ultrasound Stimulation LIPUS to Modulate the Release of Mediators Capable of Reflecting the Inflammatory State in the Affected Colonic Tract of Ulcerative Colitis Patients
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:
LIPUSinVIVO
Brief Summary:
The goal of this clinical trial is to learn whether Low Intensity Pulsed Ultrasound LIPUS is capable of promoting the release of extracellular vesicles from the gut into the bloodstream of Ulcerative Colitis UC patients whose content may be predictive of the inflammatory state of the mucosal source to aid the monitoring of the disease status and therapy response
The main questions it aims to answer are
Is LIPUS effective in inducing the release of biomarker-containing micro-vesicles into the bloodstream capable of reflecting the inflammatory state of the mucosa during active disease
Are there any extracellular vesicle-contained biomarkers that can monitor therapy during clinical remission
Participants who undergo endoscopy and gut biopsy collection as per Standard Of Care will
undergo abdominal ultrasound to establish the distance with the target tissue and consequently set the LIPUS device to supply the optimum energy established in the protocol
before LIPUS stimulation and 2 hours after stimulation patients will have blood drawn
an extra intestinal biopsy during endoscopy will be collected
patients will be contacted 72h after intervention for adverse events monitoring
The main questions it aims to answer are
Is LIPUS effective in inducing the release of biomarker-containing micro-vesicles into the bloodstream capable of reflecting the inflammatory state of the mucosa during active disease
Are there any extracellular vesicle-contained biomarkers that can monitor therapy during clinical remission
Participants who undergo endoscopy and gut biopsy collection as per Standard Of Care will
undergo abdominal ultrasound to establish the distance with the target tissue and consequently set the LIPUS device to supply the optimum energy established in the protocol
before LIPUS stimulation and 2 hours after stimulation patients will have blood drawn
an extra intestinal biopsy during endoscopy will be collected
patients will be contacted 72h after intervention for adverse events monitoring
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