Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624579
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis the CONF-UC Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis the CONF-UC Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
CONF-UC
Brief Summary:
This study employs a prospective single-center interventional design to investigate the prognostic value of confocal endomicroscopy in assessing treatment response in ulcerative colitis UC patients receiving small molecules
Detailed Description:
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy potentially enhancing the detection of treatment response and mucosal healing
Eligible patients will undergo baseline assessment including clinical evaluation partial Mayo score calculation endoscopic evaluation biopsies with histological evaluation and confocal endomicroscopy Follow-up assessments will be conducted at 8 weeks and 6 months after initiating therapy with small molecules
The study aims to enroll a sample size of 26 UC patients to pilot the feasibility and utility of confocal endomicroscopy in assessing barrier dysfunction and treatment response
Eligible patients will undergo baseline assessment including clinical evaluation partial Mayo score calculation endoscopic evaluation biopsies with histological evaluation and confocal endomicroscopy Follow-up assessments will be conducted at 8 weeks and 6 months after initiating therapy with small molecules
The study aims to enroll a sample size of 26 UC patients to pilot the feasibility and utility of confocal endomicroscopy in assessing barrier dysfunction and treatment response
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