Ileocolic IntussusceptionPAITUWDSNCT05823792
Performance of Artificial Intelligence Tools and Ultrasonographers With Different Skills
An observational study of Ileocolic Intussusception, run by Hongkui Yu， MD at 1 site in China.
Trial summary
Artificial intelligence versus different skilled sonographers. Read more about this study
- Who is it for?
- Ages 3 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Ileocolic Intussusception
- What is being tested?
- Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgery
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2023to 10 May 2023
- 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 3 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3-36 months with suspected ileocolic intussusception
Who may be able to join
- Children aged 3-36 months with suspected ileocolic intussusception
Who cannot join
- Children younger than 3 months or older than 36 months with suspected ileocolic intussusception
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hongkui Yu， MD
Guangzhou, Guangdong, 510623
Hongkui Yu，, +86 18938691272, hongkuiyu@126.com
About this study
Official title: Comparison of Artificial Intelligence and Ultrasonographers With Different Skills in Diagnosing Intussusception in Children and Identifying Indications for Surgery
Artificial intelligence versus different skilled sonographers.
Read the detailed description
Comparison of artificial intelligence and ultrasonographers with different skills in diagnosing intussusception in children and identifying indications for surgery.
- Conditions
- Ileocolic Intussusception
- Being tested
- Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgeryDiagnostic test
Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 3-36 months with suspected ileocolic intussusception | Patients aged 3-36 months with suspected ileocolic intussusception Receives: Diagnostic Test: Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound diagnosis of ileocolic intussusception
Ultrasound diagnosis of ileocolic intussusception
Measured: April 9, 2023 to May 10, 2023
Secondary outcomes (1)
Surgical indication of ileocolic intussusception identified by ultrasound
Surgical indication of ileocolic intussusception identified by ultrasound
Measured: April 9, 2023 to May 10, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start9 Apr 2023
- Primary completion10 May 2023 (estimated)
- Study completion10 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileocolic IntussusceptionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongkui Yu， MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongkui Yu， MD, Guangzhou Women and Children's Medical Center
- Investigators
- Hongkui Yu，, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823792
- Sponsor's protocol ID
- GuangzhouWCMC20230409
- Acronym
- PAITUWDS
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For non-commercial use in research, you can contact Prof. Hongkui Yu to get the data at hongkuiyu@126.com.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Artificial Intelligence and Ultrasonographers With Different Skills in Diagnosing Intussusception in Children and Identifying Indications for Surgery
- ClinicalTrials.gov ID
- NCT05823792
- Acronym / sponsor ID
- PAITUWDS / GuangzhouWCMC20230409
- Conditions
- Ileocolic Intussusception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hongkui Yu， MDUniversity, hospital or other
- Study start
- 9 Apr 2023 (actual)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 10 May 2023 (estimated)
- First posted
- 21 Apr 2023 (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.
Artificial intelligence versus different skilled sonographers.
Detailed description
Comparison of artificial intelligence and ultrasonographers with different skills in diagnosing intussusception in children and identifying indications for surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 3-36 months with suspected ileocolic intussusception | – | Diagnostic Test: Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgeryPatients aged 3-36 months with suspected ileocolic intussusception |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3-36 months with suspected ileocolic intussusception
Key inclusion criteria (1 listed)
- Children aged 3-36 months with suspected ileocolic intussusception
Key exclusion criteria (1 listed)
- Children younger than 3 months or older than 36 months with suspected ileocolic intussusception
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 |
|---|---|---|
| Non-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgeryNon-invasive diagnosis of ileocolic intussusception by ultrasound with indication for surgery | Diagnostic test | Patients aged 3-36 months with suspected ileocolic intussusception |
Primary outcome
Ultrasound diagnosis of ileocolic intussusception
Time frame: April 9, 2023 to May 10, 2023
Ultrasound diagnosis of ileocolic intussusception
1 secondary outcome
Surgical indication of ileocolic intussusception identified by ultrasound
Time frame: April 9, 2023 to May 10, 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: Yes. For non-commercial use in research, you can contact Prof. Hongkui Yu to get the data at hongkuiyu@126.com.
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.
Hongkui Yu， principal investigator
Guangzhou Women and Children's Medical Center
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 Ileocolic Intussusception, run by Hongkui Yu， MD 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 1 inclusion and 1 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 Apr 2023. 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?
Contact Hongkui Yu (+86 18938691272, hongkuiyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound diagnosis of ileocolic intussusception (time frame: April 9, 2023 to May 10, 2023). 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 Apr 2023.