NCT04770675

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 833 (actual)
• Sponsor: Qmed Consulting A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tumor
• Hemoptysis
• Pulmonary Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bronchoscopy	All subjects who are scheduled for a bronchoscopy may be eligible.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-02-25
• Last updated: 2022-05-03

Locations

1 site across 1 country: Denmark