Clinical trial NCT05463523: A Multi-centric Clinical Trial in China for Skin Diseases Intelligent Diagnosis and Treatment System
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Diseases
Artificial Intelligence
Augmented Reality
Medical Imaging
Keywords: Augmented Reality
Skin Tumor
Surgery Plan and Navigation
Dignosis and Treatment
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Doctors' Evaluation
timeFrame: Give an evaluation immediately after using the system and equipment.
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
References: