Compare Operational Performance of Three Technology in Lung ModelsNCT06741267
The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment
A study testing RBS, AB and ENB in people with Compare Operational Performance of Three Technology in Lung Models, run by Guangzhou Medical University at 1 site in Chad.
Trial summary
Recruit 30 trainee physicians from 6 centers and compare their performance in operating lung models using automatic bronchoscopy, robotic bronchoscopy, and electromagnetic navigation bronchoscopy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Compare Operational Performance of Three Technology in Lung Models
- What is being tested?
- RBS, AB and ENB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChad
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The recruited participants were respiratory internal medicine trainees undergoing further training.
- They were willing to undertake relevant training and complete the experiment persistently -
Who cannot join
- If the participant has any previous clinical or simulated experiences involving electromagnetic navigation bronchoscopy, robotic bronchoscopy system, or fluoroscopy bronchoscopy, they will be excluded.
- -
Trial locations and contacts
1 site in 1 country.
Chad1 site
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
Guangzhou, Guangdong, 510100
About this study
Official title: The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment: a Multicenter, Randomized-Controlled Trial.
Recruit 30 trainee physicians from 6 centers and compare their performance in operating lung models using automatic bronchoscopy, robotic bronchoscopy, and electromagnetic navigation bronchoscopy.
- Being tested
- RBS, AB, ENB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBSDevice
physicians control RBS
ABDevice
physician control automatic bronchoscopy
ENBDevice
physicians control electromagnetic bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| RBS group | Other | physicians control robotic bronchoscopy system(RBS) Receives: Device: RBS |
| AB group | Other | physicians control automatic bronchoscopy(AB) Receives: Device: AB |
| ENB groups | Other | physicians control electromagnetic navigation bronchoscopy(ENB) Receives: Device: ENB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sampling time
Sampling time , the time used to sample
Measured: During the bronchoscopy
Secondary outcomes (1)
Total time
total procedure time
Measured: During the bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compare Operational Performance of Three Technology in Lung ModelsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shiyue, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741267
- Sponsor's protocol ID
- automatic bronchoscopy
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cold KM, Xie S, Nielsen AO, Clementsen PF, Konge L. Artificial Intelligence Improves Novices' Bronchoscopy Performance: A Randomized Controlled Trial in a Simulated Setting. Chest. 2024 Feb;165(2):405-413. doi: 10.1016/j.chest.2023.08.015. Epub 2023 Aug 23.
PubMed 37619664
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment: a Multicenter, Randomized-Controlled Trial.
- ClinicalTrials.gov ID
- NCT06741267
- Acronym / sponsor ID
- automatic bronchoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Dec 2024 (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.
Recruit 30 trainee physicians from 6 centers and compare their performance in operating lung models using automatic bronchoscopy, robotic bronchoscopy, and electromagnetic navigation bronchoscopy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RBS group | Other | Device: RBSphysicians control robotic bronchoscopy system(RBS) |
| AB group | Other | Device: ABphysicians control automatic bronchoscopy(AB) |
| ENB groups | Other | Device: ENBphysicians control electromagnetic navigation bronchoscopy(ENB) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The recruited participants were respiratory internal medicine trainees undergoing further training.
- They were willing to undertake relevant training and complete the experiment persistently -
Key exclusion criteria (2 listed)
- If the participant has any previous clinical or simulated experiences involving electromagnetic navigation bronchoscopy, robotic bronchoscopy system, or fluoroscopy bronchoscopy, they will be excluded.
- -
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 |
|---|---|---|
| RBSphysicians control RBS | Device | RBS group |
| ABphysician control automatic bronchoscopy | Device | AB group |
| ENBphysicians control electromagnetic bronchoscopy | Device | ENB groups |
Primary outcome
Sampling time
Time frame: During the bronchoscopy
Sampling time , the time used to sample
1 secondary outcome
Total time
Time frame: During the bronchoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 37619664Cold KM, Xie S, Nielsen AO, Clementsen PF, Konge L. Artificial Intelligence Improves Novices' Bronchoscopy Performance: A Randomized Controlled Trial in a Simulated Setting. Chest. 2024 Feb;165(2):405-413. doi: 10.1016/j.chest.2023.08.015. Epub 2023 Aug 23.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RBS, AB and ENB in people with Compare Operational Performance of Three Technology in Lung Models, run by Guangzhou Medical University at 1 site in Chad.
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 2 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 18 Dec 2024. 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 Chad. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sampling time (time frame: During the bronchoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06741267, which also lists 1 linked publication.
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 18 Dec 2024.