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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; Tumor; Hemoptysis
• Intervention / Treatment: Diagnostic test: Bronchoscopy

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).

• Study Type: Observational
• Enrollment (Actual): 833

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment group; Any subject who is scheduled to undergo bronchoscopy as per routine clinical practice	Diagnostic test: Bronchoscopy; All subjects who are scheduled for a bronchoscopy may be eligible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of anatomical segments accessed during bronchoscopy	accurate photo documentation of all 18 anatomical segments +/- abnormalities	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Qmed Consulting A/S
• Collaborators: Ambu A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: bronchoscope
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Hemorrhage; Signs and Symptoms, Respiratory; Hemoptysis
• Other Study ID Numbers: CIS-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Provide data to Ambu A/S that can not be identified without the identification log.
• IPD Sharing Time Frame: 2 years after study end
• IPD Sharing Access Criteria: restricted access with user accounts to electronic data capture system
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No