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OpenTrials
Completed

NCT Number: NCT04770675

Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.

The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

2.000 subjects, preferable 150-200 number of patients per site. The 2.000 videos will be divided into an 80%/20% split (training and testing). It is a wish to obtain a spread of videos coming from across Europe, preferable from Germany, France and Denmark, with up to 800 videos coming from Denmark

The patient population indicated are patients indicated for full airway bronchoscopy. Of this group it is the aim to enrol the following:

  • Patients with obstructing tumors (when tumor blocks the view of the camera) - no more than 5% (120 patients) of studies
  • Bronchoscopies on indication of haemoptysis (active bleeding) - no more than 5% (120 patients) of studies
  • Patients with stents or valves - no more than 5% (120 patients) of studies bronchoscopies.
  • Patients with former lung operations, partial or full resections - no more than 2% (48 patients).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Oral and written participant information has been given (NA for Denmark)
  • The subject has signed informed consent (NA for Denmark)
  • Patients indicated for full airway bronchoscopy (identifying all 18 anatomical segments)
  • Patients older than 18

Exclusion criteria

  • Subject with serious lung disease which investigator considers not appropriate for this examination.
  • Lack of patient cooperation for bronchoscopy (patient with mental disorders, dysgnosia, psychological disorder…)
  • Subjects unable to give consent (NA for Denmark)

Treatment and study plan

Bronchoscopy

Diagnostic Test

All subjects who are scheduled for a bronchoscopy may be eligible.

Primary outcomes

  1. Number of anatomical segments accessed during bronchoscopy

    Time frame: 1 day

    accurate photo documentation of all 18 anatomical segments +/- abnormalities

Secondary outcomes

  1. Number of anatomical segments identified

    Time frame: 1 day

    Identified anatomical segments by the core lab/ Identified anatomical segments by the Machine Learning (after training, using the test videos).

  2. Rate of total number of lesions detected

    Time frame: 1 day

    total lesions detected by the core lab/ total lesions detected by Machine Learning (after training, using the test videos).

  3. Number of sections and lesions detected by core lab and machine learning

    Time frame: 1 day

    Anatomical sections + lesions detected by core lab versus anatomical sections + lesions detected by machine learning

Sponsors and collaborators

Lead sponsor

Qmed Consulting A/S

Industry

Collaborators

  • Ambu A/S

Registry information

Official study title

A Prospective, Multicenter, Post Market Study to Collect Data for Software Recognizing the Anatomical Structures as Well as Abnormalities in the Lung During a Bronchoscopy.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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