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JOURNAL ONKOLOGIE – STUDIE
ANDA

Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

Noch nicht rekrutierend

NCT-Nummer:
NCT04740606

Studienbeginn:
März 2021

Letztes Update:
24.02.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Multiple Pulmonary Nodules

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Guangzhou Institute of Respiratory Disease

Collaborator:
Thoraxklinik University of Heidelberg, Yashoda Health Care Services PVT, West China Hospital,

Kontakt

Studienlocations
(2 von 2)

Guangzhou Institute of Respiratory Diseases
510000 Guangzhou
China» Google-Maps

Studien-Informationen

Detailed Description:

This is a single-arm, prospective, Asian multicenter, Real World case Registry study.

Recruitment is expected to last up to 12 months, and each subject may be followed up for 12

months at most after surgery which depends on certain factors. The total duration of the

study is about 24 months.The research is planned to be carried out at more than 10 sites.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Age ≥18;

2. Chest thin-layer CT show that the peripheral pulmonary nodule (maximum diameter ≤3 cm)

is not clearly diagnosed, and planned to be sampled and diagnosed by Augmented Reality

Navigation System guided bronchoscopy;

3. The target nodule is evaluated as being able to be reached via bronchoscope under the

guidance of Augmented Reality Navigation System before procedure;

4. Patients can understand the study and sign informed consent form.

Exclusion Criteria:

-

1. Contraindications for bronchoscopy:

1. Myocardial infarction whithin 1 month.

2. Active massive hemoptysis.

3. Coagulation dysfunction.

4. Pregnancy.

5. Malignant arrhythmia, severe cardiac insufficiency, extreme systemic failure, etc.

2. Severe cardiopulmonary dysfunction and other diseases that may significantly increase

the risk of procedure; 3. The situations in which the investigators consider that patients

are not suitable for this study.

Studien-Rationale

Primary outcome:

1. Diagnostic yield (Time Frame - Six months):
It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.



Secondary outcome:

1. Diagnostic yield (Time Frame - Twelve months):
It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.

2. Success rate of biopsy (Time Frame - Immediately after Each Operation):
It is defined as the percentage of nodules with successful biopsy.

3. Navigation success rate (Time Frame - Immediately after Each Operation):
It is defined as the percentage of nodules whose arrival is confirmed by endobronchial ultrasound (and/or fluoroscopy, or direct bronchoscopy).

4. Total navigation time (Time Frame - Immediately after Each Operation):
It is defined as the total time from the beginning of navigation to the end of navigation.

5. Bronchoscope operation time (Time Frame - Immediately after each operation):
It is defined as the total time of bronchoscope insertion to bronchoscope withdrawal.

Geprüfte Regime

  • Augmented Reality Navigation System:
    Investigators will assess the nodules based on the CT images of subjects before procedure. And then, the appropriate intra-airway path planned by the Augmented Reality Navigation System will be selected. The bronchoscopy with intra-airway navigation under the guidance of the Augmented Reality Navigation System will be performed and the following surgical information will be record.

Quelle: ClinicalTrials.gov


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