A Multi-centric Clinical Trial in China for Skin Diseases Intelligent Diagnosis and Treatment System

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05463523
Collaborator
(none)
1,000
1
41

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: A Real-time Augmented Reality Device with Artificial Intelligence Integration
N/A

Detailed Description

Database: Relying on the preliminary foundation, build the first standardized infrared multispectral image database of skin diseases, and further integrate other medical images and medical history texts to iterate into a large multimodal skin disease database.

Model: Design a deep learning network based on multi-scale and multi-level. The collaborative attention learning network realizes the collaborative representation of multi-modal data at the feature level, builds a multi-modal skin disease auxiliary diagnosis model, and realizes breakthroughs in algorithms.

System: proposes a hybrid learning framework under the condition of sample imbalance, and develops a hybrid multi modal auxiliary diagnosis system enhances the ability to diagnose small samples of diseases; establishes an incremental learning system under the condition of adding new samples, develops an incremental multi-modal auxiliary diagnosis system, and realizes accurate diagnosis of newly added samples. Equipment: Based on the self-developed high-performance system, construct and assemble infrared multi-spectral skin disease auxiliary diagnosis equipment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Digital camera

A Real-time Augmented Reality Device with Artificial Intelligence Integration, acquisition of patient skin lesion images as data

Device: A Real-time Augmented Reality Device with Artificial Intelligence Integration
Patients are diagnosed and treated with the assistance of artificial intelligence, augmented reality and new optical imaging technology, which is different from traditional model.

Outcome Measures

Primary Outcome Measures

  1. Diagnosis accuracy [up to 12 months]

    Comparing AI with human diagnosis accuracy

  2. Dermatology Life Quality Index(DLQI) [up to 12 months]

    The evaluation of prognosis, the minimum values 0 and the maximum values 30, and a higher score mean a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Informed consented.

  • With a diagnosis of skin disease made by at least 3 dermatologists.

  • Without life-threatening risk to intervention.

Exclusion Criteria:
  • Having difficulties to follow-up.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Xiangya Hospital of Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier:
NCT05463523
Other Study ID Numbers:
  • XiangyaH001
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022