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

Recruiting

• Conditions: Artificial Intelligence; Augmented Reality; Medical Imaging; Skin Diseases
• Interventions: Device: A Real-time Augmented Reality Device with Artificial Intelligence Integration

• Registration Number: NCT05463523
• Lead Sponsor: Xiangya Hospital of Central South University

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.

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. Develop the segmentation network of skin lesions and model for surgery planning, including surgical margin design and navigation of intraoperative sampling.

System: Propose an artificial intelligence system combined with the real-time augmented reality to assist dignosis and surgery for skin diseases.

Equipment: Based on the self-developed high-performance system, construct and assemble infrared multi-spectral skin disease auxiliary diagnosis equipment and multifunctional device for skin tumors surgery.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-09
• Study Start: 2022-04-15
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-19
• Last Update Submitted: 2022-12-18
• Last Update Posted: 2022-12-21
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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).

Exclusion Criteria

• Having difficulties to follow-up.
• Poor general condition.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Doctors' Evaluation	Give an evaluation immediately after using the system and equipment.	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.

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, Hunan, China