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

Qmed Consulting

Status: Completed

Conditions: Pulmonary Disease; Hemoptysis; Tumor

Treatments: Diagnostic Test: Bronchoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT04770675

CIS-20

Details and patient eligibility

About

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.

Full 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).

Enrollment: 833 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

833 participants in 1 patient group

Treatment group

Description:

Any subject who is scheduled to undergo bronchoscopy as per routine clinical practice

Treatment:

Diagnostic Test: Bronchoscopy