NCT07168408

Brief Summary

Brief summary The goal of this Feasibility study is to capture bronchoscopy data from patients (Group1) and bronchoscopists (Group 2) over a period of three years. The investigators wish to collect the pre-procedure CT scans and endoscopy videos of 300 patients. Up to 20 bronchoscopists will take part in the study Primary outcomes

  1. 1.To collect imaging data from patients undergoing routine bronchoscopy procedures
  2. 2.To collect movement data from clinicians performing the routine bronchoscopy procedures using a sensory Glove
  3. 3.Integrate the data gathered with procedure guidelines to develop a representation of procedure success using machine learning algorithms.
  4. 4.Develop an actionable knowledge base for bronchoscopy skill transfer to novice/untrained medical staff.
  5. 5.Investigate the feasibility of developing models of bronchoscopy procedures to develop training tools in the future

Trial Health

77
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress64%
May 2025Dec 2026

First Submitted

Initial submission to the registry

July 17, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

July 17, 2024

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • To collect imaging data from patients undergoing routine bronchoscopy procedures

    The bronchoscopy images will be recorded using a screen capture device

    up to 1 hour

  • to collect movement data from clinicians performing the routine bronchoscopy procedures

    A sensory glove will be worn by the clinicians to capture their hand movements during the routine bronchoscopy

    up to 1 hour

Secondary Outcomes (2)

  • Integrate the data gathered with procedure guidelines to develop a representation of procedure success using machine learning algorithms

    1 year after completion of data collection

  • Investigate the feasibility of developing models of bronchoscopy procedures to develop training tools in the future.

    1 year after completion of data collection

Study Arms (2)

Group 1

Up to 300 patients undergoing routine bronchoscopy procedures. Patients will be asked permission to access previous CT scans and record video from the bronchoscopy procedure.

Group 2

Up to 20 bronchoscopists. These participants will be asked a to complete a short questionnaire on their experience and will wear a sensorized glove to capture their hand movements during the procedure

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Group 1- Patients undergoing a routine, clinically indicated bronchoscopy procedure Group 2- Clinicians currently involved in performing bronchoscopy procedures

You may qualify if:

  • over 16 years of age
  • patients identified as requiring a bronchoscopy by their clinician
  • patients must have had a CT scan in the 8 weeks prior to the procedure
  • capacity to consent

You may not qualify if:

  • \- Suitably qualified bronchoscopists, this may include trainee bronchoscopists
  • Clinicians who do not give consent to participate in the study
  • Clinicians who are not comfortable performing bronchoscopy while wearing the lightweight glove

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

September 11, 2025

Study Start

May 6, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Data generated by the study (including personal data) will not be transferred to external individuals or organisations outside of the sponsoring organisations

Locations