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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Diseases; Artificial Intelligence; Augmented Reality; Medical Imaging
• Intervention / Treatment: Device: A Real-time Augmented Reality Device with Artificial Intelligence Integration

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital
      • Contact: Kai Huang; Phone Number: 13080564083; Email: 1145371482@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Estimate): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Augmented Reality; Skin Tumor; Surgery Plan and Navigation; Dignosis and Treatment
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: XiangyaH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No