Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263413
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-08
Brief Title:
Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions
Sponsor:
AI Labs Group SL
Organization:
AI Labs Group SL
Study Overview
Official Title:
Optimization of Clinical Workflow in Patients With Various Dermatological Conditions Through Artificial Intelligence
Status:
RECRUITING
Status Verified Date:
2024-03
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:
IDEI_2023
Brief Summary:
Artificial intelligence AI based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field Amid the COVID-19 pandemic limited access to in-person healthcare services drove shifts in medical care hastening the adoption of telemedicine In this context AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance In dermatology pigmented lesions acne and alopecia are three recurring pathology groups with high demand in dermatological centers Both triage clinical evaluation and patient follow-up require in-person resources and specialist dedication Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload
Advancements in image recognition and interpretation as well as in artificial intelligence have spurred innovations in diagnosing various pathologies including skin conditions Computer-Aided Diagnosis CAD systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician
In this study the LegitHealth tool developed by AI LABS GROUP SL which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions will be evaluated The purpose of this tool is to automatically prioritize patients with greater urgency assign the type of consultation dermatological or aesthetic enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff and provide a visual record photograph of the condition for later review by external experts
Thus the main objective of this study is to validate that LegitHealth based on Artificial Intelligence improves efficiency in clinical flow and patient care processes thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination
The secondary objectives focus on measuring the diagnostic performance of LegitHealth
Demonstrate that LegitHealth enhances healthcare professionals39 ability to detect malignant or suspicious pigmented lesions
Demonstrate that LegitHealth improves healthcare professionals39 ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia
Demonstrate that LegitHealth improves healthcare professionals39 ability and precision in measuring the degree of involvement in patients with acne
Additionally the study aims to assess the utility of this tool
Automate the triageinitial assessment process in patients presenting with pigmented lesions
Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation esthetic or dermatological
Evaluate LegitHealth39s usability by the patient Demonstrate that LegitHealth increases specialist satisfaction Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation whether in aesthetic or dermatological settings
Methodology Study Design Type This is an observational study both prospective with a longitudinal character and retrospective case series
Study Period This study estimates a recruitment period of 3 months The total study duration is estimated at 6 months including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing data analysis and preparation of the final study report
The total study duration for each participant with pigmented lesions will be 1-3 months The duration for patients with acne and alopecia will be 1 day
Study Population Adult patients 18 years with skin pathologies treated at the Dermatology Unit of IDEI
Advancements in image recognition and interpretation as well as in artificial intelligence have spurred innovations in diagnosing various pathologies including skin conditions Computer-Aided Diagnosis CAD systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician
In this study the LegitHealth tool developed by AI LABS GROUP SL which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions will be evaluated The purpose of this tool is to automatically prioritize patients with greater urgency assign the type of consultation dermatological or aesthetic enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff and provide a visual record photograph of the condition for later review by external experts
Thus the main objective of this study is to validate that LegitHealth based on Artificial Intelligence improves efficiency in clinical flow and patient care processes thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination
The secondary objectives focus on measuring the diagnostic performance of LegitHealth
Demonstrate that LegitHealth enhances healthcare professionals39 ability to detect malignant or suspicious pigmented lesions
Demonstrate that LegitHealth improves healthcare professionals39 ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia
Demonstrate that LegitHealth improves healthcare professionals39 ability and precision in measuring the degree of involvement in patients with acne
Additionally the study aims to assess the utility of this tool
Automate the triageinitial assessment process in patients presenting with pigmented lesions
Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation esthetic or dermatological
Evaluate LegitHealth39s usability by the patient Demonstrate that LegitHealth increases specialist satisfaction Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation whether in aesthetic or dermatological settings
Methodology Study Design Type This is an observational study both prospective with a longitudinal character and retrospective case series
Study Period This study estimates a recruitment period of 3 months The total study duration is estimated at 6 months including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing data analysis and preparation of the final study report
The total study duration for each participant with pigmented lesions will be 1-3 months The duration for patients with acne and alopecia will be 1 day
Study Population Adult patients 18 years with skin pathologies treated at the Dermatology Unit of IDEI
Detailed Description:
Artificial intelligence AI based on images presents enormous potential for improving visual diagnostic accuracy in the medical field During the COVID-19 pandemic limited access to in-person healthcare services drove changes in medical care accelerating the adoption of telemedicine In this context the use of AI for triage and decision support can be crucial for professionals to manage workload and improve performance In dermatology pigmented lesions acne and alopecia are three recurring pathology groups with high demand in a dermatological center Both triage of these patients clinical evaluation and their follow-up require in-person resources and the dedication of the specialist and staff The use of tools like AI can benefit these professionals in reducing these processes and optimizing the workload
Advances in image recognition and interpretation as well as in artificial intelligence have driven innovations in diagnosing various pathologies including skin conditions Computer-Aided Diagnosis CAD systems and other algorithm-based technologies have demonstrated their ability to classify lesion images with a competency comparable to that of an expert physician
In this study the LegitHealth tool developed by AI LABS GROUP SL which uses artificial intelligence to optimize clinical flow and the care process of patients with skin conditions will be evaluated The purpose of this tool is the automatic prioritization of patients with greater urgency assigning them the type of consultation dermatological or aesthetic improving the diagnostic capacity and detection of malignant pigmented lesions in auxiliary staff as well as providing a visual record photograph of the condition for later review by external experts
Thus the main objective of this study is to validate that the LegitHealth tool based on Artificial Intelligence improves efficiency in clinical flow and the care process of patients reducing the time and cost of care per patient through enhanced diagnostic accuracy and determination of the degree of malignancy or severity
The secondary objectives focus on measuring the diagnostic performance of LegitHealth
Demonstrate that LegitHealth improves the ability of healthcare professionals to detect malignant or suspicious pigmented lesions
Demonstrate that LegitHealth improves the ability and precision of healthcare professionals in measuring the degree of involvement in patients with female androgenetic alopecia
Demonstrate that LegitHealth improves the ability and precision of healthcare professionals in measuring the degree of involvement in patients with acne
Additionally the study aims to assess the utility of this tool
Automate the triageinitial assessment process in patients consulting for pigmented lesions
Evaluate the reduction in healthcare resource usage by the center by reducing the number of triage consultations and directly referring the patient to the appropriate consultation esthetic or dermatological
Evaluate LegitHealth39s usability by the patient Demonstrate that LegitHealth increases specialist satisfaction Evaluate the reduction in healthcare resource usage by reducing the number of triage consultations and directly referring the patient to the appropriate consultation whether in aesthetic or dermatological settings
Methodology
Study Design Type
This is an observational study both prospective with a longitudinal character and retrospective case series
Study Period
This study estimates a recruitment period of 3 months
The total study duration is estimated at 6 months including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing data analysis and preparation of the final study report
The total study duration for each participant with pigmented lesions will be 1-3 months The duration for patients with acne and alopecia will be 1 day
Study Population
Adult patients 18 years with skin pathologies treated at the Dermatology Unit of IDEI
Advances in image recognition and interpretation as well as in artificial intelligence have driven innovations in diagnosing various pathologies including skin conditions Computer-Aided Diagnosis CAD systems and other algorithm-based technologies have demonstrated their ability to classify lesion images with a competency comparable to that of an expert physician
In this study the LegitHealth tool developed by AI LABS GROUP SL which uses artificial intelligence to optimize clinical flow and the care process of patients with skin conditions will be evaluated The purpose of this tool is the automatic prioritization of patients with greater urgency assigning them the type of consultation dermatological or aesthetic improving the diagnostic capacity and detection of malignant pigmented lesions in auxiliary staff as well as providing a visual record photograph of the condition for later review by external experts
Thus the main objective of this study is to validate that the LegitHealth tool based on Artificial Intelligence improves efficiency in clinical flow and the care process of patients reducing the time and cost of care per patient through enhanced diagnostic accuracy and determination of the degree of malignancy or severity
The secondary objectives focus on measuring the diagnostic performance of LegitHealth
Demonstrate that LegitHealth improves the ability of healthcare professionals to detect malignant or suspicious pigmented lesions
Demonstrate that LegitHealth improves the ability and precision of healthcare professionals in measuring the degree of involvement in patients with female androgenetic alopecia
Demonstrate that LegitHealth improves the ability and precision of healthcare professionals in measuring the degree of involvement in patients with acne
Additionally the study aims to assess the utility of this tool
Automate the triageinitial assessment process in patients consulting for pigmented lesions
Evaluate the reduction in healthcare resource usage by the center by reducing the number of triage consultations and directly referring the patient to the appropriate consultation esthetic or dermatological
Evaluate LegitHealth39s usability by the patient Demonstrate that LegitHealth increases specialist satisfaction Evaluate the reduction in healthcare resource usage by reducing the number of triage consultations and directly referring the patient to the appropriate consultation whether in aesthetic or dermatological settings
Methodology
Study Design Type
This is an observational study both prospective with a longitudinal character and retrospective case series
Study Period
This study estimates a recruitment period of 3 months
The total study duration is estimated at 6 months including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing data analysis and preparation of the final study report
The total study duration for each participant with pigmented lesions will be 1-3 months The duration for patients with acne and alopecia will be 1 day
Study Population
Adult patients 18 years with skin pathologies treated at the Dermatology Unit of IDEI
Study Oversight
Has Oversight DMC:
None
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?:
None