Clinical trial NCT04770675: Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor
Hemoptysis
Pulmonary Disease
Keywords: bronchoscope
Lead sponsor: Qmed Consulting A/S
Sponsor class: INDUSTRY
Collaborators: name: Ambu A/S
First posted: 2021-02-25
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The bronchoscope is used to confirm or exclude a diagnosis in adult patients with airway complaints to identify a potential disease.

Brief summary: 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.

Detailed description: 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:

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of anatomical segments accessed during bronchoscopy
timeFrame: 1 day
Secondary outcomes:
measure: Number of anatomical segments identified
timeFrame: 1 day
measure: Rate of total number of lesions detected
timeFrame: 1 day
measure: Number of sections and lesions detected by core lab and machine learning
timeFrame: 1 day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Michael Perch, MD
role: PRINCIPAL_INVESTIGATOR
References: