A Multi-centric Clinical Trial in China for Skin Diseases Intelligent Diagnosis and Treatment System
Based on Artificial Intelligence, Augmented Reality and New Optical Imaging Technology, the Research and Development of a Skin Diseases Intelligent Diagnosis and Treatment System: A Multi-centric Clinical Trial in China
1 other identifier
observational
200
1 country
1
Brief Summary
In response to clinical needs, infrared multi-spectral images are combined with traditional clinical images and other multi-modal data to build a more efficient intelligent auxiliary diagnosis system and intelligent equipment for skin health and diseases, including skin lesions automatically segmentation on skin diseases images, automatically design surgical margin and planning for skin tumor surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 21, 2022
December 1, 2021
1.7 years
December 9, 2021
December 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Doctors' Evaluation
Compare the proposed system's perfomance with the doctors in the terms of the diganosis and lesion segmentation. After using the system and the device, doctors evaluated its performance on the Skin Lesion Boundary Description, Margin Design, Sampling Navigation, Projection Effect, Security, Time-consuming and Convenience. 0-10 points for each indicator is scored independently by 4 doctors.
Give an evaluation immediately after using the system and equipment.
Study Arms (1)
Digital camera
A Real-time Augmented Reality Device with Artificial Intelligence Integration, acquisition of patient skin lesion images as data
Interventions
Patients are diagnosed and treated with the assistance of artificial intelligence, augmented reality and new optical imaging technology, which is different from traditional model.
Eligibility Criteria
Study population is diagnosed of skin disease made by at least 3 dermatologists. For population who needs to use the system and device, requires surgical treatment and willing to underwent a new modality. Exclusions include poor general condition and having difficulties to follow-up.
You may qualify if:
- Informed consented.
- With a diagnosis of skin disease made by at least 3 dermatologists.
- Without life-threatening risk to intervention.
- Requires surgical treatment (For devices).
You may not qualify if:
- Having difficulties to follow-up.
- Poor general condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangya Hospital
Changsha, Hunan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2021
First Posted
July 19, 2022
Study Start
April 15, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2025
Last Updated
December 21, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share