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

Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04770675
• Other study ID #: CIS-20
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Qmed Consulting A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 833
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemoptysis
• Pulmonary Disease
• Tumor

Intervention

Diagnostic Test:
• Bronchoscopy
All subjects who are scheduled for a bronchoscopy may be eligible.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Qmed Consulting A/S	Ambu A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of anatomical segments accessed during bronchoscopy	accurate photo documentation of all 18 anatomical segments +/- abnormalities	1 day
Secondary	Number of anatomical segments identified	Identified anatomical segments by the core lab/ Identified anatomical segments by the Machine Learning (after training, using the test videos).	1 day
Secondary	Rate of total number of lesions detected	total lesions detected by the core lab/ total lesions detected by Machine Learning (after training, using the test videos).	1 day
Secondary	Number of sections and lesions detected by core lab and machine learning	Anatomical sections + lesions detected by core lab versus anatomical sections + lesions detected by machine learning	1 day