Skin DiseasesNCT05463523
A Multi-centric Clinical Trial in China for Skin Diseases Intelligent Diagnosis and Treatment System
An observational study of Skin Diseases and Artificial Intelligence, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases, Artificial Intelligence, Augmented Reality
- What is being tested?
- A Real-time Augmented Reality Device with Artificial Intelligence Integration
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Having difficulties to follow-up.
- Poor general condition.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital
Changsha, Hunan
Kai Huang, 13080564083, 1145371482@qq.com
About this study
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
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.
Read the 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.
- Being tested
- A Real-time Augmented Reality Device with Artificial Intelligence Integration
- Keywords
- Augmented Reality, Skin Tumor, Surgery Plan and Navigation, Dignosis and Treatment
- Medical subject headings
- Skin Diseases, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Real-time Augmented Reality Device with Artificial Intelligence IntegrationDevice
Patients are diagnosed and treated with the assistance of artificial intelligence, augmented reality and new optical imaging technology, which is different from traditional model.
| Study group | Role | What they receive |
|---|---|---|
| Digital camera | A Real-time Augmented Reality Device with Artificial Intelligence Integration, acquisition of patient skin lesion images as data Receives: Device: A Real-time Augmented Reality Device with Artificial Intelligence Integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Give an evaluation immediately after using the system and equipment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start15 Apr 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463523
- Sponsor's protocol ID
- XiangyaH001
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05463523
- Acronym / sponsor ID
- XiangyaH001
- Keywords
- Augmented Reality, Skin Tumor, Surgery Plan and Navigation, Dignosis and Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital camera | – | Device: A Real-time Augmented Reality Device with Artificial Intelligence IntegrationA Real-time Augmented Reality Device with Artificial Intelligence Integration, acquisition of patient skin lesion images as data |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Having difficulties to follow-up.
- Poor general condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Real-time Augmented Reality Device with Artificial Intelligence IntegrationPatients are diagnosed and treated with the assistance of artificial intelligence, augmented reality and new optical imaging technology, which is different from traditional model. | Device | Digital camera |
Primary outcome
Doctors' Evaluation
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases and Artificial Intelligence, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doctors' Evaluation (time frame: Give an evaluation immediately after using the system and equipment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.