The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment

December 16, 2024 updated by: Li Shiyue, Guangzhou Medical University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chad
    • Guangdong
      • Guangzhou, Guangdong, Chad, 510100
        • The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RBS group
physicians control robotic bronchoscopy system(RBS)
Device: RBS
physicians control RBS
Other: AB group
physicians control automatic bronchoscopy(AB)
Device: AB
physician control automatic bronchoscopy
Other: ENB groups
physicians control electromagnetic navigation bronchoscopy(ENB)
Device: ENB
physicians control electromagnetic bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sampling time
Time Frame: During the bronchoscopy
Sampling time , the time used to sample
During the bronchoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time
Time Frame: During the bronchoscopy
total procedure time
During the bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • automatic bronchoscopy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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