Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 11:01 AM
Study NCT ID:
NCT04844593
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2021-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Use of Natural Language Processing (NLP) and Machine Learning (ML) for the Identification of Patients With Crohn's Disease (CD) and Complex Perianal Fistulas (CPF) and Their Characterization in Terms of Clinical and Demographic Characteristics. A Multicentre, Retrospective, NLP Based Study
Status:
COMPLETED
Status Verified Date:
2024-05
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:
INTUITION-CPF
Brief Summary:
Natural Language Processing and machine learning are examples of artificial intelligence tools. This study will check if these tools correctly identify people with Crohn's disease with complex perianal fistulas from their medical records.
Detailed Description:
This is a non-interventional, retrospective study of participants with CD and CPF in a clinical practice setting.
The study will enroll approximately 100 participants.
The study will have a retrospective data collection to select and analyze information from EMRs processed by an AI based analytics framework that uses machine learning and NLP methodologies.
All participants will be enrolled in one observational group.
• Participants with CD
This multi-center trial will be conducted in Spain. The overall duration of the study is approximately 36 months.
The study will enroll approximately 100 participants.
The study will have a retrospective data collection to select and analyze information from EMRs processed by an AI based analytics framework that uses machine learning and NLP methodologies.
All participants will be enrolled in one observational group.
• Participants with CD
This multi-center trial will be conducted in Spain. The overall duration of the study is approximately 36 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: