Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT06710067
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Metabolites in the Diagnosis of Disease
Sponsor:
Luventix, Inc.
Organization:
Study Overview
Official Title:
Observational Study of Urine Metabolites in the Diagnosis of Disease
Status:
RECRUITING
Status Verified Date:
2024-11
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 goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases.
This research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn\'s disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease.
The main questions it aims to answer are:
1. Does the platform identify a disease signal within each disease cohort, compared to normal controls?
2. How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?
This research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn\'s disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease.
The main questions it aims to answer are:
1. Does the platform identify a disease signal within each disease cohort, compared to normal controls?
2. How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 20242000 | OTHER | WCG IRB | View |