---
title: Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.
nct_id: NCT04770675
overall_status: COMPLETED
sponsor: Qmed Consulting A/S
study_type: OBSERVATIONAL
primary_condition: Tumor
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04770675.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04770675"
ct_last_update_post_date: 2022-05-03
last_seen_at: "2026-05-12T06:28:26.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.

**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.

**NCT ID:** [NCT04770675](https://clinicaltrials.gov/study/NCT04770675)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 833
- **Lead Sponsor:** Qmed Consulting A/S
- **Collaborators:** Ambu A/S
- **Conditions:** Tumor, Hemoptysis, Pulmonary Disease
- **Start Date:** 2020-12-01
- **Completion Date:** 2021-12-31
- **CT.gov Last Update:** 2022-05-03

## Brief 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **Treatment group** — Any subject who is scheduled to undergo bronchoscopy as per routine clinical practice

## Interventions

- **Bronchoscopy** (DIAGNOSTIC_TEST) — All subjects who are scheduled for a bronchoscopy may be eligible.

## Primary Outcomes

- **Number of anatomical segments accessed during bronchoscopy** _(time frame: 1 day)_ — accurate photo documentation of all 18 anatomical segments +/- abnormalities

## Secondary Outcomes

- **Number of anatomical segments identified** _(time frame: 1 day)_
- **Rate of total number of lesions detected** _(time frame: 1 day)_
- **Number of sections and lesions detected by core lab and machine learning** _(time frame: 1 day)_

## Locations (1)

- Rigshospitalet, Copenhagen, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.rigshospitalet|copenhagen||denmark` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04770675.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04770675*  
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