Observational Bronchoscopy Video Data Collection Study With Adult Patients

NCT ID: NCT06465797

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-08

Study Completion Date

2024-02-09

Brief Summary

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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

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A data collection of bronchoscopy videos from 100-150 patients are enrolled for getting image material of different lung anatomies, captured with CE-marked and FDA-approved Ambu bronchoscopes (AmbuĀ® aScopeā„¢ 5 Broncho HD). No intervention will take place, only standard of care. All types of indications are enrolled. All patients were given oral and written information prior to participating, and signed consent was provided. No patient identifiable information is stored.

Conditions

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Lung Diseases Lung Neoplasms Lung Cancer Lung Transplantation Lung Diseases, Obstructive

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Bronchoscopy

No intervention will take place in this study, only image material will be captured from the standard-of-care bronchoscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients indicated for bronchoscopy of central airways as per standard of care
* Patients of 18 years or above

Exclusion Criteria

* Lack of patient cooperation for bronchoscopy (e.g. patients with mental disorders, dysgnosia, psychological disorder)
* Patients unable or unwilling to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Ambu A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Ambu A/S

Identifier Type: -

Identifier Source: org_study_id

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