NCT05248347

Brief Summary

We evaluated the effects of different fiberbronchoscopy training in how to teach and assess performance. Resident participants with no experience of fiberbronchoscopy, and doctors with little clinical experience with fiberbronchoscopy were eligible for the study.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

February 9, 2022

Last Update Submit

February 18, 2022

Conditions

Keywords

FiberbronchoscopySimulationAssessmentValidity

Outcome Measures

Primary Outcomes (1)

  • Final score for examination by Bronchoscopy training simulator

    Final score of manipulation, orientation, anatomy and actual operation

    through study completion, an average of 3 months

Secondary Outcomes (4)

  • % time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator

    through study completion, an average of 3 months

  • % time at mid-lumen

    through study completion, an average of 3 months

  • % time at mid-lumen for fiberbronchoscopy manipulation

    through study completion, an average of 3 months

  • Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator

    through study completion, an average of 3 months

Study Arms (2)

Bronchoscopy training simulator

ACTIVE COMPARATOR

Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) was used to train the participants.

Device: Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan)

The BRONCH Mentor

EXPERIMENTAL

Group B: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA) was used.

Device: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)

Interventions

Participants who passed the theory test and was enrolled in this group will use this device to practice. After the appropriate time of practice, the test will be taken to evaluate the efficacy.

Bronchoscopy training simulator

Participants who passed the theory test and was enrolled in this group will use this device to practice. After the appropriate time of practice, the test will be taken to evaluate the efficacy.

The BRONCH Mentor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Doctors with little experience of fiberbronchoscopy

You may not qualify if:

  • Resident participants who can not complete the study.
  • Resident participants who can not pass the theroy examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210000, China

RECRUITING

Study Officials

  • Jingyuan Xu, M.D.

    Southeast University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 21, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

February 21, 2022

Record last verified: 2022-02

Locations