Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hemoptysis
- Pulmonary Disease
- Tumor
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 T...
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: Patients with obstructing tumors (when tumor blocks the view of the camera) - no more than 5% (120 patients) of studies Bronchoscopies on indication of haemoptysis (active bleeding) - no more than 5% (120 patients) of studies Patients with stents or valves - no more than 5% (120 patients) of studies bronchoscopies. Patients with former lung operations, partial or full resections - no more than 2% (48 patients).
Tracking Information
- NCT #
- NCT04770675
- Collaborators
- Ambu A/S
- Investigators
- Principal Investigator: Michael Perch, MD Rigshospitalet, Denmark