NCT06741267

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

December 5, 2024

Last Update Submit

December 16, 2024

Conditions

Compare Operational Performance of Three Technology in Lung Models

Outcome Measures

Primary Outcomes (1)

  • Sampling time

    Sampling time , the time used to sample

    During the bronchoscopy

Secondary Outcomes (1)

  • Total time

    During the bronchoscopy

Study Arms (3)

RBS group

OTHER

physicians control robotic bronchoscopy system(RBS)

Device: RBS

AB group

OTHER

physicians control automatic bronchoscopy(AB)

Device: AB

ENB groups

OTHER

physicians control electromagnetic navigation bronchoscopy(ENB)

Device: ENB

Interventions

RBSDEVICE

physicians control RBS

RBS group
ABDEVICE

physician control automatic bronchoscopy

AB group
ENBDEVICE

physicians control electromagnetic bronchoscopy

ENB groups

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The recruited participants were respiratory internal medicine trainees undergoing further training.
  • They were willing to undertake relevant training and complete the experiment persistently -

You may not qualify if:

  • If the participant has any previous clinical or simulated experiences involving electromagnetic navigation bronchoscopy, robotic bronchoscopy system, or fluoroscopy bronchoscopy, they will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163

Guangzhou, Guangdong, 510100, Chad

Location

Related Publications (1)

  • 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.

    PMID: 37619664BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 18, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)